Delay antiretroviral therapy initiation and factors affecting it among patients on antiretroviral treatment at North Shewa zone public health facilities, Amhara region, Ethiopia, 2024: a mixed method approach

Abstract

Background

Although the beginning of antiretroviral therapy shortly after HIV infection results in better outcomes compared to waiting until symptoms appear, globally, there is a research gap in this area. Specifically, in Ethiopia, where the burden of the disease is high, little is known about the timing of the initiation, and previous studies assessed the area either qualitatively or quantitatively only. Therefore, this study aimed to assess the factors that affect the timely initiation of ART by employing a mix of both qualitative and quantitative methods in the North Shewa Zone of the Amhara region in Ethiopia.

Methods

A concurrent mixed method was used to gather information about antiretroviral therapy initiators in health facilities under the North Shewa zonal health department from February to April 2024. A total of 596 patients were selected using a multistage random sampling method for the quantitative study, while 28 participants were selected for the qualitative study using purposive sampling. The quantitative data were collected using structured data collection forms, and interview guides supported by an audio recorder were used for qualitative data. The quantitative part was uploaded to the Kobo toolbox for collection. Bivariable and multivariable logistic regression analyses were used to determine the relationships between the independent and dependent variables. The quantitative data were analyzed using Stata version 16.0 software, while the qualitative data were analyzed thematically by OpenCode version 4.03 software. The P-value of less than 0.05 was declared statistically significant. The qualitative data were analyzed thematically.

Result

The prevalence of delayed ART initiation was 22% (95% CI, 18.99–25.67%). Individuals who had ambulatory functional status (AOR 2.65, 95% CI 1.18–5.97), clients who took prophylaxis for opportunistic infection (AOR 5.77, 95% CI 2.16–15.41), prior opportunistic infection (AOR 3.93, 95% CI 1.89–8.16) and disclosure status (AOR 0.46, 95% CI 0.26–0.82) were significantly associated with delay ART initiation. Moreover, the qualitative findings revealed clinical, client, and provider/facility-related challenges.

Conclusion

The study highlights a high prevalence of delayed antiretroviral therapy initiation compared to the WHO test and treat target, with factors result disclosure status, functional status, baseline OI prophylaxis, and OI development. Therefore, client counseling should focus on disclosure, ensuring HIV-positive linkage to ART, and provision of OI prophylaxis and treatment as per the updated guidelines.

Clinical trial

Not applicable.

Supplementary Information

The online version contains supplementary material available at 10.1186/s12879-026-12715-x.

Background

A delay in initiating antiretroviral therapy (ART) occurs when treatment begins more than seven days after the diagnosis of human immunodeficiency virus (HIV) in patients without tuberculosis (TB) or cryptococcal meningitis. If left untreated, HIV can progress to acquired immunodeficiency syndrome (AIDS), which significantly heightens the risk of infections, including TB and various cancers, by compromising the immune system and diminishing the effectiveness of white blood cells. The encouraging aspect is that starting ART early can successfully prevent the progression to AIDS [1, 2].

Since 2016, the World Health Organization has strongly recommended that all adults living with HIV begin ART regardless of their clinical stage or Cluster of Differentiation four (CD4) cell count [3]. This “treat-all” approach has been adopted by over 130 countries worldwide, including Ethiopia [3]. Studies have shown that starting ART early after an HIV diagnosis can significantly improve health outcomes, increase survival rates, reduce the incidence of opportunistic infections, and offer HIV prevention benefits for families and communities [1].

As of the end of 2022, approximately 39 million people worldwide were living with HIV infections, with about 4.99 million of them located in Africa [4]. In that year, there were 1.3 million new HIV infections globally, including 177,000 in Africa. Additionally, 630,000 people died from AIDS-related causes worldwide, with 125,300 of those deaths occurring in Africa.

Roughly three-fourths of individuals eligible for treatment globally had access to antiretroviral therapy (ART). Among these individuals, 82% of pregnant individuals with HIV had access to ART, which helps prevent the transmission of HIV to their babies during pregnancy and childbirth while also safeguarding their own health. In Ethiopia, it was estimated that over half a million people—specifically, 610,000—were living with HIV/AIDS in 2022, with three-fourths of those eligible receiving ART. In 2019, around 208,000 people were living with HIV in the Amhara region, making it one of the regions with the highest HIV burdens [4–8].

The use of ART is now widespread and has significantly improved outcomes for those living with HIV [9]. This medication is designed to inhibit the multiplication of HIV, with the potential to suppress the virus to undetectable levels in the bloodstream. As a result, a person’s immune system can recover, enabling them to fight off infections and prevent the development of AIDS and other long-term effects of HIV infection. Starting antiretroviral therapy early after infection, rather than delaying treatment until symptoms arise, maximizes these benefits and can prevent HIV-related illnesses and save lives [9, 10]. All individuals who test positive for HIV are eligible for ART and should begin treatment immediately once their diagnosis is confirmed, unless they have tuberculosis or cryptococcal meningitis [1, 3, 9].

The United Nations Program on HIV/AIDS (UNAIDS) has established a Fast-Track target to reduce new HIV infections by the year 2030 [11], with the ultimate goal of ending the HIV epidemic worldwide by that date. This plan incorporates the 90-90-90 strategy, which aims to ensure that 90% of people living with HIV are aware of their status, 90% of those who know their status have access to antiretroviral therapy (ART), and 90% of those receiving ART achieve viral load suppression. Recently, the Fast-Track target has been updated to 95%, with the aim of reaching this goal by 2030. Currently, only 81% of people living with HIV are aware of their HIV status, and 67% are on antiretroviral therapy. Of those on therapy, only 59% have achieved viral suppression. To meet the second and third 95% global and national targets, rapid initiation of ART will play a crucial role, as it is beneficial for individuals with acute infections. It helps minimize loss before linkage to care, limits viral replication, and decreases the duration of viral suppression [10–13].

To reduce morbidity and mortality and prevent the transmission of HIV, antiretroviral therapy is recommended for all individuals with HIV, regardless of their CD4 count or WHO clinical stage [14]. A panel on Antiretroviral Guidelines for Adults and Adolescents suggests starting ART immediately or as soon as possible after an HIV diagnosis. This approach aims to improve uptake and linkage to care, reduce the time to viral suppression, and enhance overall viral suppression among individuals with HIV [14].

However, there are challenges to initiating ART early, which stem from factors related to clients, healthcare providers, and health facilities [15]. Client-related factors that may delay ART initiation include living far from a healthcare facility, low socioeconomic background, couples testing before marriage, lack of knowledge about other ART users, absence of an HIV-positive family member, substance abuse, non-disclosure of HIV status, and lack of trust in healthcare professionals or testing procedures. Additionally, patients with normal nutritional status, good CD4 counts, and those with opportunistic infections may be hesitant to start ART early. Furthermore, the type of healthcare facility and inadequate patient counseling and linkage can impact the timely initiation of ART [15–20].

Previous studies assessed the area either qualitatively or quantitatively only. Therefore, this study aimed to assess the factors that affect the timely initiation of ART by employing a mix of both qualitative and quantitative methods in the North Shewa Zone of the Amhara region in Ethiopia.

Methods

Study setting

The study was conducted in the North Shewa zone, Amhara region, Ethiopia. The administrative center is Debre Berhan town, which is located in the North Shewa Zone in the Amhara Region, about 130 km northeast of Addis Ababa on the highway to Dessie, and 695 km from the regional town, Bihar Dar. According to the 2023 population projection, the zone has a total population of 2,412,446(1,237,485 males and 1,174,961 females) [21, 22].

Quarter one (September 2023) North Shewa zonal health department report indicates there are 10 government and 1 private hospital, along with 30 health centers, serving 11,403 ART clients. Since 2016, all facilities have implemented same-day ART initiation following HIV confirmation by rapid test. At hospitals, both doctors and nurses initiate ART, while at health centers, only trained nurses do. The study was conducted from February to April 2024 and included retrospective secondary data of clients who initiated ART from September 2020 to August 2023 for quantitative findings, irrespective of the date their HIV was confirmed.

Study design

A concurrent mixed design (quantitatively by cross-sectional and qualitatively through phenomenological) was used to assess the delay for ART initiation and associated factors among patients who start ART in the North Shewa zone, Amhara region, Ethiopia, 2024. The reason why the mixed method design was employed was due to the fact that delayed ART initiation is influenced by both measurable factors and contextual experiences. While qualitative research investigated the underlying causes and perspectives, the quantitative data assessed the extent of the delay and its predictors. Moreover, the data obtained by combining the two methods helps to guide focused intervention.

Eligibility criteria

Exclusion criteria

Exclusion criteria for qualitative

Health care providers who had transferred to other health facilities during data collection were excluded from this study.

Sample size determination and sampling procedure

Quantitative

The sample size was calculated using a single population proportion ( ) with the assumption of a 95% level of confidence, 4% margin of error, 34.4% Proportion of delay ART initiation detected in a study done in Gojjam [18], and a 10% non-response rate provided 596. Study subjects were selected by using a multi-stage random sampling technique, and 03 Hospitals and 05 Health centers were selected randomly. Then, participants were included in the study until the calculated sample size was achieved by using a simple random sampling method from the selected hospitals and health centers. The size of the sample from each facility was proportional to the number of newly initiated ART initiations from September 2020 to August 2023. A list of clients’ medical record numbers who started ART from September 2020 to August 2023 extracted from EMR_ART served as a sampling frame. ,

Qualitative

Participants were identified using purposive sampling by a maximum variation strategy. We varied them based on age category [<25 (2), 25–40 (20), > 40 (6)], sex (Males 16 and Females 12), and service providers’ experience in ART [<5 years (6), 5-9 years (4), 10 years and above (7)] [23]. This process continued until saturation among newly initiated patients, healthcare providers, and treatment assistants (case managers and adherence supporters). In total, 28 participants (11 patients, 12 healthcare providers, and 5 treatment assistants) selected from three hospitals and five health centers were purposively selected from the eight designated health facilities. There were also 5 participants who refused to participate due to mistrust of the purpose of the study.

Study variables

Outcome variable

The outcome variable in this study was the delay for ART initiation, categorized into a binary format. A response of “yes” to the question “Did the client start ART in a delayed manner?” was assigned a value of 1, while a response of “no” was assigned a value of 0.

Independent variables

The study included several key independent variables, which are summarized in (Table 1).

Table 1.

Independent variables of the study and their categorization

Variable	Categorization	Remark
Age	“<15” =0, “15–24” =1, “25–34” =2, “35–44” =3, “45+” =4	Categorized by the Authors after data was collected
Religion	“Orthodox Christian” =1, “Muslim” =2, “Protestant” =3	Categorized from the standard data source
Marital Status	“Married” =1, “Never Married” =2, “Divorced” =3, “Widowed” =4, “Separated” =5	Categorized from the standard data source
Educational Status	“No formal education” =1, “Primary” =2, “Secondary” =3, “Tertiary” =4, “Other” =5	Categorized from the standard data source
Main Current Occupation	“Government employee” =1, “Private worker” =2, “House Wife” =3, “Merchant” =4, “Student” =5, “Farmer” =6, “Laborer” 7, “Jobless” =8, “Other” =9	Categorized from the standard data source
Residence	“Rural” =1, “Urban” =2	Categorized from the standard data source
ART Providing HF Type	“Hospital” =1, “Health Center” =2	Categorized from the standard data source
Health facility type where an HIV-positive result was diagnosed	“Public Hospital” =1, “Health center” =2, “private clinic” =3, “Community testing outlets” =4, “NGO” =5	Categorized from the standard data source
Referral Information	“With in the same health facility” =1, “Outside the health facility” =2	Categorized from the standard data source
HIV Testing Modality	“Voluntary counselling and testing (VCT)” =1 “Medical outpatient department (MOPD)” =2, “Index case HIV testing (ICT)” =3, “Key population (KP) Clinic” =4, “Inpatient department (IPD)” =5, “Maternal and child health (MCH)” =6, “Other Service delivery points (Other SDP)” =7, “Other health facilities (Other HF)” =8	Categorized from the standard data source
HIV Positive result disclosure Status	“Not disclosed” =0, “Disclosed” =1	ART providers are categorized based on the disclosure definition from the ART guideline
HIV-Positive result disclosed for: Spouse, Sibling, Parent, Relative, Child, Friend	“No” =0, “Yes” =1 “Spouse” =1, “Sibling” =2, “Parent” =3, “Relative” =4, “Child” =5, “Friend” =6, “Other specify = 7”	Categorized from the standard data source
Has an HIV-positive family	“No” =0, “Yes” =1	Categorized from the standard data source
Phone Number (Registered at patient folder/EMR)	“No” =0, “Yes” =1	Data collector categorized based on intake A form completeness
Pregnancy Status	“No” =0, “Yes” =1, “Na (Males and females out of reproductive age” =3	Categorized from the standard data source
WHO Clinical Stage	“Stage one” =1, “Stage two” =2, “Stage three” =3, “Stage four” =4	Categorized from the standard data source
Functional status	“Working” =1, “Ambulatory” =2, “Bedridden” =3	Categorized from the standard data source
Developmental millstone	“Appropriate” =1, “Delay” =2, “Regular” =3	Categorized from the standard data source
Nutritional Status	“Normal” =1, “Mild” =2, “Moderate” =3, “Severe” =4, “Overweight” =5	Authors were categorized based on anthropometry measurement results after the data was collected
Received any prophylaxis for OI	“No” =0, “Yes” =1	Data collectors are categorized based on the source data
Prophylaxis type: TPT, CPT	“TPT” =1, “CPT” =2	Categorized from the standard data source
Developed an Opportunistic infection	“No” =0, “Yes” =1	Data collectors are categorized based on the source data
Types of Opportunistic Infections: TB, Pneumonia, Oral Candidiasis, Other OI	“TB” =1, “Pneumonia” =2, “Oral Candidiasis” =3, “Other OI” =4	Categorized from the standard data source
CD4 Count	“<200” =1, “200–499” =2, “500+” =3, “Not done” = 999	Categorized by the Authors after data was collected
Hemoglobin	“<8” =1, “8-9.99” =2, “10-11.99” =3, “12-15.99” =4, “16+” =5	Categorized by the Authors after data was collected

Operational definitions

• Rapid ART initiation (not delayed) was considered:

  • For those who have no opportunistic infections (OIs: receiving ART within 7 days of post-HIV diagnosis.
  • For those diagnosed and found to have additional OIs:
    • ART initiation within 2 weeks following the anti-TBC regimen started, 8 weeks if TB meningitis.
    • ART initiation within 4 weeks following an amphotericin B-based regimen or within 6 weeks following a fluconazole-based regimen started for Cryptococcal meningitis,

• ART initiation within 2 weeks following PCP treatment started [1].

• Delayed ART initiation was defined as initiation of ART beyond the above set schedule [1].

• HIV positive result disclosure status:

  • Disclosed: the one who informs others, such as Partners, Parents, Siblings, Relatives, Friends, and Others about their HIV positive result.
  • No disclosed: the one who doesn’t inform anyone about their HIV positive result [24].

Data collection tools and procedures

Quantitative

Two nurses who have worked with people living with HIV were responsible for collecting data, and 01 public health officer for supervision. The data collectors explained the study to the facility head and obtained consent from him/her, and the eligible clients’ charts were retrieved from their archival and extracted from the EMR_ART database. The data collectors reviewed all necessary variables from the data sources and filled out the data extraction form. The data extraction tool was adapted from the HIV Care/ART Follow-Up Form and previously studied literature [25] (refer to Supplementary Document 1).

Qualitative

The principal investigator collected the data through in-depth interviews using paper-based interview guides specifically developed for this study (refer to Supplementary Document 2). The guides were prepared in English and translated into Amharic, with a back-translation performed to ensure consistency. Participants were interviewed for 30 min on average, both face-to-face and by telephone, based on ease of access. The interviews were audio-recorded and subsequently transcribed into text format.

Data management and analysis

Quantitative

The collected data were exported from the Kobo toolbox to Excel and thoroughly checked for completeness and consistency. Subsequently, the data were transferred to Stata version 16.0 for analysis. Frequency tables, graphs, and summary statistics were done for descriptive purposes. Multicollinearity was checked among selected independent variables using the variance inflation factor (VIF); VIF = 1 shows variables are not correlated, between 1 and 5 shows variables are moderately correlated, and VIF 5–10 shows variables are highly correlated [26]. Variables that were significant at P-value < 0.25 in the bivariable analysis were considered in the multivariable analysis while adjusting and controlling for the effect of possible confounders. Corresponding Odds Ratio (OR) and Adjusted Odds Ratio (AOR) along with their confidence interval for the bivariable and multivariable analysis were also outputted. The model was selected based on the Log-likelihood (Log-LL) value, which shows the highest number. Goodness-of-fit-test statistics for logistic regression were checked using Hosmer-Lemeshow, which was 0.2348.

Qualitative

Each interview was accompanied by comprehensive field notes. Audio recordings were then transcribed verbatim and returned to participants for their comments. Upon receiving and correcting the comment researcher translated it into English. Next, the data were organized through thematic analysis using an inductive approach. The principal investigator subsequently analyzed the transcript and manually coded relevant concepts using OpenCode version 4.03 software.

Inclusion criteria

Inclusion criteria for quantitative

All patients newly initiated on ART from September 2020 to August 2023 in North Shewa zone ART service, providing public health Facilities.

Inclusion criteria for qualitative

All patients who started ART between September 2020 and August 2023 at the public health facilities providing ART services in North Shewa zone, along with ART providers and care supporters who had a minimum of one year of experience in the study area, were included in the study.

Results

Quantitative results

Sociodemographic characteristics

The study comprised 596 participants, 360(60.4%) females. The mean age of participants was 32.2 years, with a standard deviation of ± 12.2 years. The majority, constituting 517(86.7%), identified as Orthodox Christians, while 269(45.1%) were married, 387(64.9%) had received formal education, and 394(66.1%) were urban dwellers (Table 2).

Table 2.

Socio-demographic characteristics of clients receiving ART at public health institutions in North Shewa, Amhara region, Ethiopia, 2024

Types of Variables	Freq. (%) of Delay ART Initiation			X2 -value	P-value
	Rapid (%)	Delay (%)	Total (%)
Age in year
< 15	30(5.03)	7(1.17)	37(6.21)	3.2051	0.524
15–24	85(14.26)	24(4.03)	109(18.29)
25–34	161(27.01)	45(7.55)	206(34.56)
35–44	111(18.62)	40(6.71)	151(25.34)
45+	77(12.92)	16(2.68)	93(15.6)
Religion
Orthodox Christian	392(65.77)	125(20.97)	517(86.74)	9.5677	0.008*
Muslim	67(11.24	7(1.17)	74(12.42)
Protestant	5(0.84)	0(0.00)	5(0.84)
Marital Status
Married	208(34.9)	61(10.23)	269(45.13)	2.6115	0.625
Never Married	122(20.47)	31(5.2)	153(25.67)
Divorced	108(18.12)	36(6.04)	144(24.16)
Widowed	24(4.03)	4(0.67)	28(4.7)
Separated	2(0.34)	0(0.00)	2(0.34)
Educational Status
No formal education	165(28.5)	44(7.6)	209(36)	3.3396	0.503
Primary	176(30.3)	53(9.1)	229(39.5)
Secondary	76(13.1)	27(4.7)	103(17.8)
Tertiary	34(5.9)	5(0.9)	39(6.7)
Other	13(2.2)	3(0.5)	16(2.7)
Main Current Occupation
Government employee	29(4.9)	6(1)	35(5.9)	4.8239	0.776
Private worker	75(12.6)	23(3.9)	98(16.4)
House Wife	90(15.1)	33(5.5)	123(20.6)
Merchant	53(8.9)	11(1.9)	64(10.7)
Student	31(5.2)	10(1.7)	41(6.9)
Farmer	102(17.1)	26(4.4)	128(21.5)
Laborer	27(4.5)	10(1.7)	37(6.2)
Jobless	21(3.5)	6(1)	27(4.5)
Other	36(6)	7(1.2)	43(7.2)
Residence
Rural	133(22.3)	69(11.6)	202(33.9)	25.5649	< 0.001*
Urban	331(55.5)	63(10.6)	394(66.1)

*The variable affects delay ART initiation

Health facility-related characteristics of study participants

The majority of the participants, 212(35.6%), were selected from the Debre Berhan cluster, and 351(58.9%) were recruited from the health center. Nearly three-fourths, 436(73.2), of the participants were diagnosed within the ART initiation health facility. Out of these 332(76.1%) of them tested using a provider-initiated testing and counseling strategy (Table 3).

Table 3.

Health facility-related characteristics of clients receiving ART at public health institutions in North Shewa, Amhara region, Ethiopia, 2024

Types of Variables	Freq. (%) of Delay ART Initiation			X2 -value	P-value
	Rapid (%)	Delay (%)	Total (%)
ART Providing HF Type
Hospital	165(27.7)	80(13.4)	245(41.1)	26.6276	< 0.001*
Health Center	299(50.2)	52(8.7)	351(58.9)
health facility types where HIV positive results diagnosed
Public Hospital	155(26.3)	71(12.1)	226(38.4)	17.267	< 0.001*
Health center	231(39.2)	45(7.6)	276(46.9)
NGO	71(12.1)	16(2.7)	87(14.8)
Referral Information
Within the same health facility	343(57.6)	93(15.6)	436(73.2)	0.6293	0.428
Outside the health facility	121(20.3)	39(6.5)	160(26.9)
Testing Modality
VCT	83(13.9)	21(3.5)	104(17.5)	16.9826	0.018*
MOPD	108(18.1)	41(6.9)	149(25)
ICT	30(5)	3(0.5)	33(5.5)
KP Clinic	32(5.4)	2(0.3)	34(5.7)
IPD	14(2.4)	6(1)	20(3.4)
MCH	60(10.1)	11(1.9)	71(11.9)
Other SDP*	16(2.7)	9(1.5)	25(4.2)
Other HF**	121(20.3)	39(6.5)	160(26.9)

SDP*= Service delivery point

HF**= Health facility

*= The variable affects delay ART initiation

Client-related characteristics of the participant

Less than half, 265(44.5%) of patients had disclosed their HIV status to their contacts. Of these, the majority, 133(50.2%), disclosed to their spouse. Most, 481(80.7%) of the participants had a registered cell phone number in their medical record (Table 4).

Table 4.

Client-related characteristics of participants receiving ART at public health institutions in North Shewa, Amhara region, Ethiopia, 2024

Types of Variables	Freq. (%) of Delay ART Initiation			X2_value	P-value
	Rapid (%)	Delay (%)	Total (%)
HIV Positive result disclosure Status
Not disclosed	239(40.1)	92(15.4)	331(55.5)	13.7674	< 0.001*
Disclosed	225(37.8)	40(6.7)	265(44.5)
HIV-Positive results disclosed for:
Spouse	124(46.8)	27(10.2)	151(57)
Sibling	32(12.1)	3(1.1)	35(13.2)
Parent	40(15.1)	9(3.4)	49(18.5)
Relative	6(2.3)	0(0)	6(2.3)
Child	17(6.4)	1(0.4)	18(6.8)
Friend	10(3.8)	1(0.4)	11(4.2)
Cases	225	40	265
Has HIV Positive family
Yes	48(8.1)	11(1.9)	59(9.9)	0.4662	0.495
No	416(69.8)	121(20.3)	537(90.1)
Phone Number
Yes	374(62.8)	107(18)	481(80.7)	0.0138	0.907
No	90(15.1)	25(4.2)	115(19.3)

Baseline clinical characteristics of the participant

The majority of participants were clinically stage one, 406(68.1%), had a working functional status, 509(87%), well-nourished 343(57.6%). Among the reproductive-age women, 67(21.8%) were pregnant during ART initiation. Only 30% and 15% of participants had baseline CD4 count and hemoglobin level, respectively, since there was a CD4 reagent shortage in Ethiopia from 2020 to 2023. The mean CD4 count was 272.8(SD ± 235) cells/mm3, and hemoglobin level was also measured with the CD4 machine as a trend in the study areas. Whereas the mean hemoglobin level was 13.9 (SD ± 3.6) gm/dl. Most study participants, 559(93.8%), didn’t take any prophylaxis for opportunistic infections. Nearly 12% of subjects developed opportunistic infections, with TB taking the highest share of the burden at 45(68.2%) (Table 5).

Table 5.

Baseline clinical characteristics of clients receiving ART at public health institutions in North Shewa, Amhara region, Ethiopia, 2024

Types of Variables	Freq. (%) of Delay ART Initiation			X2 -value	P-value
	Rapid (%)	Delay (%)	Total (%)
Pregnancy Status
Yes	58(9.7)	9(1.5)	67(11.2)	5.4687	0.065
No	178(29.9)	63(10.6)	241(40.4)
NA	228(38.3)	60(10.1)	288(48.3)
WHO Clinical Stage
Stage one	326(54.7)	80(13.4)	406(68.1)	14.1101	0.003*
Stage two	57(9.6)	10(1.7)	67(11.2)
Stage three	67(11.2)	33(5.5)	100(16.8)
Stage four	14(2.4)	9(1.5)	23(3.9)
Functional status
Working	411(70.3)	98(16.8)	509(87)	20.6134	< 0.001*
Ambulatory	36(6.2)	28(4.8)	64(10.9)
Bedridden	8(1.4)	4(0.7)	12(2.1)
Developmental millstone
Appropriate	7(63.64)	1(9.09)	8(72.73)	1.7569	0.415
Delay	1(9.09)	0(0)	1(9.09)
regular	1(9.09)	1(9.09)	2(18.18)
Nutritional Status
Normal	274(46)	69(11.6)	343(57.6)	6.9673	0.138
Mild	69(11.6)	23(3.9)	92(15.4)
Moderate	68(11.4)	20(3.4)	88(14.8)
Severe	29(4.9)	16(2.7)	45(7.6)
Overweight	24(4)	4(0.7)	28(4.7)
Received Any prophylaxis for OI
Yes	10(1.7)	27(4.5)	37(6.2)	59.1013	< 0.001*
No	454(76.2)	105(17.6)	559(93.8)
Prophylaxis type
TPT	3(30)	10(37)	13(35.1)	-	-
CPT	8(80)	20(74.1)	28(75.7)
Cases	10	27	37
Developed Opportunistic infection
Yes	37(6.21)	48(8.05)	85(14.26)	67.7351	< 0.001*
No	427(71.64)	84(14.09)	511(85.74)
Types of Opportunistic infection
TB	21(24.7)	25(29.4)	46(54.1)
Pneumonia	10(11.8)	4(4.7)	14(16.5)
Oral Candidiasis	3(3.5)	5(5.9)	8(9.4)
Other OI	10(11.8)	21(24.7)	31(36.5)
Cases	37	48	85
CD4 Count
< 200	60(10.1)	33(5.5)	93(15.6)	15.1915	0.002*
200–499	33(5.5)	14(2.4)	47(7.9)
500+	28(4.7)	9(1.5)	37(6.2)
not done	343(57.6)	76(12.8)	419(70.3)
Hemoglobin
< 8	1(0.2)	0(0)	1(0.2)	6.9252	0.226
8-9.99	6(1)	5(0.8)	11(1.9)
10-11.99	10(1.7)	4(0.7)	14(2.4)
12-15.99	27(4.5)	10(1.7)	37(6.2)
16+	19(3.2)	9(1.5)	28(4.7)
measured	401(67.3)	104(17.5)	505(84.7)

*=The variable affects delay ART initiation

Delay antiretroviral initiation

Among the study subjects, 22.2% (95% CI:18.99–25.67) (n/N = 132/596) had a delay in initiating antiretroviral therapy. More than half 57% (n/N = 337/596) of them initiated ART on the same day of their HIV diagnosis. Meanwhile, 19% (n/N = 115/596), 11.7% (n/N = 70/596), and 12.4% (n/N = 74/596) of the subjects were initiated ART 1–7 days, 8–30 days (12 of them due to OI treatment), and beyond 30 days after diagnosis, respectively. This delay in ART initiation varied across different sociodemographic, behavioral, health facility, and clinical characteristics.

Factors associated with delayed antiretroviral therapy initiation

In the bivariable logistic regression analysis, we examined the role of various independent variables related to the outcome variable of delayed ART initiation at a p-value less than 0.25. The independent variables include residence, ART-providing health facility type, HIV testing modality, result disclosure status, WHO clinical stage, functional status, receiving prophylaxis for OI prevention, and development of OI. These variables were associated with the outcome variable delayed ART initiation at the 0.25 significance level in the bivariable analysis and then considered for the subsequent multivariable analysis. The variables that were found at 0.05 level of significance in the final multivariable logistic regression model were HIV-positive result disclosure status, baseline functional status, baseline OI prophylaxis, and developing OI before ART initiation.

According to the results of the study, the odds of delayed ART initiation among individuals who had ambulatory functional status were 2.65 times higher (AOR 2.65, 95% CI 1.18–5.97) compared to those who had working functional status. Clients who had taken prophylaxis for OI prevention before ART had 5.77 times higher odds of delayed ART initiation (AOR 5.77, 95% CI 2.16–15.41) than those who didn’t take any OI prophylaxis. Additionally, the study found that the odds of delayed ART initiation among clients who had developed opportunistic infection before initiating ART was 3.93 times higher (AOR 3.93, 95% CI 1.89–8.16) than individuals who had never developed any OI before ART initiation. Whereas clients who disclosed their HIV-positive result to their family had decreased delay ART initiation by 54% (AOR 0.46, 95% CI 0.26–0.82) (Table 6).

Table 6.

Factors associated with delayed ART initiation among clients receiving ART at public health institutions in North Shewa, Amhara region, Ethiopia, 2024

Variables	Outcome status		Bivariable & Multivariable Analysis
	Rapid	Delay	COR (95%CI)	AOR (95%CI)	P-value
Residence
Urban	331	63	-	-	-
Rural	133	69	2.73(1.83–4.05)	1.67(0.97–2.89)	0.065
ART Providing HF Type
Hospital	165	80	-	-	-
Health Center	299	52	0.36(0.24–0.53)	0.68(0.38–1.22)	0.197
Testing Modality
VCT	83	21	-	-
MOPD	108	41	1.5(0.82–2.73)	1.34(0.67–2.67)	0.414
ICT	30	3	0.4(0.11–1.42)	0.65(0.13–3.31)	0.603
KP Clinic	32	2	0.25(0.05–1.11)	0.48(0.10–2.32)	0.362
IPD	14	6	1.69(0.58–4.94)	1.27(0.36–4.50)	0.713
MCH	60	11	0.72(0.33–1.62)	1.00(0.41–2.45)	0.999
Other SDP	16	9	2.22(0.86–5.73)	0.97(0.29–3.31)	0.962
HIV Positive result disclosure Status
Not disclosed	239	92	-	-
Disclosed	225	40	0.46(0.31–0.7)	0.46(0.26–0.82)	0.009
WHO Clinical Stage
Stage one	326	80	-	-	-
Stage two	57	10	0.71(0.35–1.46)	0.67(0.25–1.77)	0.418
Stage three	67	33	2.01(1.24–3.25)	0.59(0.26–1.33)	0.202
Stage four	14	9	2.62(1.09–6.27)	0.84(0.23–3.04)	0.787
Functional status
Working	411	98	-	-	-
Ambulatory	36	28	3.26(1.9–5.6)	2.65(1.18–5.97)	0.018
Bedridden	8	4	2.1(0.62–7.1)	0.79(0.13–4.92)	0.803
Received any prophylaxis for OI
Yes	10	27	11.67(5.48–24.86)	5.77(2.16–15.41)	< 0.001
No	454	105	-	-	-
Developed opportunistic infection
Yes	37	48	6.59(4.05–10.75)	3.93(1.89–8.16)	< 0.001
No	427	84	-	-	-

Qualitative result

Characteristics of the participant

The study comprised 28 participants who participated in in-depth interviews. This group consisted of 11 clients, 12 health care providers, and 5 care supporters, including 3 case managers and 2 adherence supporters. The mean age of participants was 36.3 ± 7.1 years. Around 11(64.7%) of the workers had more than 5 years of experience (Table 7).

Table 7.

Socio-demographic characteristics of clients receiving ART and workers working at public health institutions in North Shewa, Amhara region, Ethiopia, 2024

Characteristics	Clients	Health care providers	Care supporters	Total
Age category
< 18	1	0	0	1
18–24	1	0	0	1
25–40	6	11	3	20
41 and above	3	1	2	6
Work experience in ART
< 5 years	-	6	0	6
5–9 years	-	4	0	4
10 years and above	-	2	5	7
Health facility name
Shewarobit Health Center	1	2	1	4
Mehalmeda Hospital	1	1	1	3
Enat Hospital	1	1		2
Rema Health Center	1	1	1	3
Arerti Health Center	1	1	1	3
Metehbila Health Center	1	1		2
Debre Berhan Hospital	3	3	1	7
Debre Berhan Health Center	2	2		4

Thematic analysis results

The study has three major themes. The first theme explores client-related factors that contribute to delayed ART initiation and includes three sub-themes: Psychological distress following HIV positive results awareness, Concerns about test accuracy and result confidentiality, and Disclosure of HIV-positive status. The second theme encompasses clinical factors of delayed ART initiation with two sub-themes: the stage of the disease at diagnosis and fear of side effects. Lastly, the third theme investigates provider/facility-related factors of delay ART initiation, containing two sub-themes: health care providers’ awareness and health facility setup (Table 8).

Table 8.

Summary of thematic analysis

Major Themes	Sub-themes	Sub-sub-themes
Client-related factors	Psychological distress following HIV positive results awareness	Panic, Denial, Need for mental preparation
	Concern about test accuracy and result confidentiality	Doubt test results, Repeat testing
	Disclosure of HIV-positive status	Family disclosure, Privacy concerns
Clinical factors	Stage of disease at diagnosis	Early-stage asymptomatic, Severe illness
	Fear of side effects	Observed side effects, Appearance concerns
Provider/facility-related factors	Healthcare provider awareness	Outdated guideline adherence
	Health facility setup	Location of ART room, Privacy concerns

Client-related factors that affect the timing of ART initiation

Psychological distress following HIV positive results awareness

In-depth interview participants reported that upon receiving they are told have HIV positive results, clients expressed feeling panicked and experienced psychological distress. They also reported initially denying the results and needing time to decide before starting any treatment.

In most cases, clients may not be mentally prepared to initiate ART immediately after undergoing initial counseling. They may require more counseling sessions and time to stabilize before being ready for ART. However, with time and continued counseling, clients tend to become more accepting of the counseling. (36-year-old ART physician)

Concerns about test accuracy and result confidentiality

As evidenced by clients who participated in in-depth interviews, misperceptions about the test process and concerns about the result confidentiality being breached by healthcare providers have also been identified as factors that prolong the duration of ART initiation. Some participants reported that they believed the test kit may be over-sensitive and could potentially provide a false positive result, leading them to visit multiple health facilities to confirm.

I was doing repeated tests in different places. Also, since I was sick with coronavirus at the time, I doubted my results, saying that the test would consider the coronavirus as HIV. Then I started when it was the same result at different places. (45 years old patient)

Others have observed clients who have a fear that their results may be disclosed to unauthorized individuals by healthcare providers, causing them to delay seeking treatment

They [clients] also delayed treatment initiation due to the perception that the healthcare providers may disclose their test results to others. (33 years old case manager)

Disclosure of HIV-positive status

Various concerns related to result disclosure have been highlighted by both clients and providers as a reason for the delayed ART initiation. According to providers, some clients wish to inform their families about their status but require additional time before they are ready to do so.

Some clients wish to inform their families about their results before initiation [ART initiation], but they struggle to find enough time to do so. (40 years old provider)

Some individuals expressed concern that their HIV status might be known to others without their willingness. The fear of seen visiting an ART clinic or having medication at home limited their ability to make an independent decision about starting ART. As a result of this perceived loss of autonomy, these patients experienced delays in ART initiation.

I was hesitant to start my treatment early because I was afraid of the possibility of others discovering my test results when I visited a health facility for treatment. (29-year-old patient)

Clients who had family worry that if someone sees their drug may disclose their results. (38-year-old provider)

Clinical conditions that affect the timing of ART initiation

Stage of the disease when they were diagnosed

Evidence from participants explored that at the early stage of HIV patients may not have any observable health problems. At this stage, they were not willing to initiate ART. Some clients reported that they don’t give priority to ART initiation and do not want to accept the health provider’s counseling since their CD4 was good.

It’s a work issue and CD4 count that made me late to initiate the treatment; I didn’t feel comfortable working and my CD4 was good. (32 years old patient)

Clients who knew their results without being very ill consider themselves to be healthy and do not think that there was any benefit to early treatment initiation. (34 years old ART focal)

On the other hand, seriously ill patients may feel hopeless about the possibility of recovery after their health has deteriorated. One client reported being refused ART initiation due to her serious illness and belief that the treatment would cause unnecessary suffering.

I was so sick that I had no hope of recovery. It was difficult for me to say that I would rather die soon than suffer from pain. (36 years old patient)

One patient also reported that she was not able to decide about HIV treatment due to she was not well-oriented regarding the level of the disease at the time of HIV diagnosis.

When I was diagnosed at the time, I was in great pain and felt disoriented; so, I couldn’t decide whether to start or not ART. (47 years old patient)

Fear of side effects

As reported by health facility workers and clients who participated in in-depth interviews, fear of drug side effects was a common reason why some client decides not to take ART. These clients are often those who have observed HIV-positive individuals who were taking previous ART regimens that had more severe side effects. For instance, one patient reported seeing various skin symptoms in an HIV patient on ART and felt hesitant to initiate ART herself due to the fear of getting sick.

I saw various symptoms on their skin in people taking antiretroviral medication, so I didn’t start early because I was afraid that it might make me sick when I started the medication too. (29 years patient)

Healthcare providers have also reported encountering clients who refuse ART initiation out of fear that it may negatively affect their health and appearance.

Some clients may be apprehensive about starting ART due to the possibility of experiencing certain issues. This was especially true if they knew someone who had previously taken a regimen that caused sleep disturbances and unnecessary fat accumulation. Such clients may fear that they too may experience these symptoms with their treatment. (36 years old physician)

Some clients are worried that the treatment might negatively impact their appearance, leading to skinny or bulge. (40 years old case manager).

Healthcare provider/facility-related factors that affect the timing of ART initiation

Healthcare provider’s awareness

According to a mentor physician’s report, some healthcare providers have not kept up to date with the latest information regarding the new HIV linkage and ART initiation process. In particular, healthcare providers working in the inpatient department still believe that admitted patients should be linked to the ART unit only after completing other treatments.

The earlier HIV treatment guideline did not permit linking clients with comorbidities to ART, which contrasts with the new guideline. However, some healthcare providers are still following outdated guidelines, leading to delays in linking HIV patients who have other comorbidities to ART. (36 years old physician)

Health facility setup

One case manager reported that there was a need for a private environment for both service providers and clients. They need a secure space to counsel clients in complete confidentiality. Additionally, Clients need a separate room, away from other treatment-providing departments. Unfortunately, their hospital’s ART clinic is located parallel to other service delivery units, which could potentially compromise the privacy of clients. This could also cause delays for clients who were coming to start ART.

The initiation of ART is being delayed due to the location of the room assigned for HIV treatment, which is situated next to other treatment units. This situation is causing anxiety among HIV patients, who fear being seen by others. Some clients who come to initiate antiretroviral treatment are also leaving without reaching the room; when they see someone they know in the adjacent department. (33 years old case manager)

Discussion

Using a mixed method approach, delay ART initiation and factors contributing to it among patients on ART were assessed. According to this study, delay initiation of ART was 22% (95% CI, 18.99–25.67%), and factors associated with this delay ART initiation were never disclosing HIV-positive results for anyone, individuals who had ambulatory functional status compared to working functional status, taking OI prophylaxis and developing OI before ART initiation.

The findings of this study are in line with a similar study done in Botswana (23%) [27]. Whereas it is higher from studies done in Changsha, China (18.1%) and West Region of Cameroon (5.1%) [28, 29]. The variation in prevalence rates between this study area and the reference community may be attributed to differences in socio-demographics and infrastructure. For instance, a study carried out in the western region of Cameron reported a lower prevalence (5.1%) compared to this study’s finding. This substantial difference in prevalence could be due to the selection nature of facility recruitment in the previous study, where facilities with higher patient loads were purposefully chosen. Additionally, these selected facilities may have received specialized support from regional technical groups for the fight against AIDS, with backing from various technical and financial partners such as the Global Fund, the US President Emergency Fund for Aids Relief, The WHO, UNICEF, etc.

On the other hand delay ART initiation prevalence in this study is comparably lower when compared to previous studies conducted in Northern Uganda (37.8%), Nekemte Referral Hospital (34%), Nekemte town (28.8%), public health institutions in Bahir Dar town (39%) and health facilities in Gojjam (34.4) [16–20]. This could be attributed to the gradual improvement in adherence and adoption of updated test and treatment strategies, as well as the implementation of different innovative approaches. There was also a guideline update that promoted rapid ART initiation [1].

In the current study, HIV–positive individuals who disclosed their status to someone had 54% lower odds of delayed ART initiation than their counterparts. This finding is consistent with previous studies conducted in Nekemte town, western Ethiopia [19]. The plausible reason may be, that disclosing HIV status can lead to the establishment of a strong support system, which may involve healthcare providers, family, friends, or healthcare supporters. This support network can provide both emotional and practical support in coping with the challenges of having HIV-positive results. Additionally, publicly sharing status can help to avoid social stigma and discrimination, and finally lead to rapid ART initiation [30–32]. The qualitative result from the in-depth interview supported this finding. An individual who fears their result may be known by others without their willing to visit an ART clinic for treatment and keeping their drug at home made them not have a free decision for ART initiation. Due to this loss of freedom, the patient had a delayed ART initiation.

Individuals with ambulatory functional status had 2.65 times the odds of delaying ART initiation compared to those with working functional status. This finding is similar to a previous study conducted in public health institutions of Bahir Dar city. The possible reason for this finding might be individuals with ambulatory functional status being unemployed, creating financial barriers for HIV patients seeking healthcare. This includes the costs of transportation. Additionally, these patients may lack social support and may experience mental health issues such as depression due to unemployment, leading to delayed initiation of ART [17].

The odds of delayed ART initiation of clients who had taken prophylaxis for opportunistic infection prevention before initiating ART were almost a times higher compared to those who did not take any prophylaxis. This may be attributed to the burden of taking prophylaxis medication can sometimes lead to delays in initiating ART. Patients may face challenges in adhering to multiple medications or may prioritize prophylaxis over starting ART due to perceived immediate benefits.

Clients who had developed an opportunistic infection before starting ART had 3.93 times higher odds of experiencing delayed ART initiation compared to those who did not develop any opportunistic infection. This finding coincides with a cross-sectional study conducted in health facilities in Gojjam [18]. The reason behind this could be that healthcare providers delay the linkage to ART unit until the completion of other treatments by following the outdated HIV care and treatment guidelines and patients having symptoms similar to TB may be delayed until their results are confirmed in facilities where not equipped with TB diagnostic machine and reagents [3]. The qualitative finding also supports this result. Healthcare providers lacked updated information regarding the new HIV linkage and ART initiation process. In particular, Health care providers working in the inpatient department still believe that admitted patients should be linked to the ART unit only after completing other treatments. Additionally, in-depth interview participants reported that they delayed ART initiation of advanced HIV patients if they suspect TB due to the absence of LF-LAM to confirm the presence and absence of TB. The limitations of this study are as follows. First, because the quantitative data were collected from secondary sources, there is potential for recording errors, which may affect the accuracy of the data. Second, previously diagnosed clients may have recall bias when reporting the reasons for delay in the qualitative part of the analysis, possibly leading to inaccurate findings. Lastly, the qualitative analysis was conducted without using advanced qualitative analysis software, which may have limited the depth or reliability of the analysis.

Conclusions

A high prevalence of delayed ART initiation was found compared to the WHO test and treat target. Factors of delay ART initiation were HIV-positive result disclosure status, functional status, baseline OI prophylaxis, and OI development which arises from client and clinical-related reasons. Therefore, the study will recommend the care supporters and health care providers at the ART department of the health facility enhance client counseling regarding disclosure, properly employ different disclosure approaches, ensure HIV-positive clients’ linkage to ART early before other OI treatments, and provision of OI prophylaxis and treatment as of the updated HIV care and treatment guideline. This study also suggests that community-based organizations provide strong counseling and support to HIV-positive individuals who don’t start ART.

Supplementary Information

Below is the link to the electronic supplementary material.

Abbreviations

ADL

Activity of Daily Living

AIDS

Acquired Immune Deficiency Syndrome

AOR

Adjusted Odds Ratio

ART

Anti-Retro Viral Therapy

CD4

Cluster of Differentiation four

CI

Confidence Interval

HC

Health Center

HIV

Human Immune Deficiency Virus

INH

Isoniazid

OI

Opportunistic Infection

PCP

Pneumocystis Pneumonia

PITC

Provider Initiated Testng And Counselling

PLWHA

People Living With HIV/AIDS

TB

Tuberculosis

UNAIDS

United Nations Program on HIV/AIDS

VCT

Voluntary Counselling and Testing

WHO

World Health Organization

Author contributions

Conceptualization: MWM Data curation: MWM, AHB & ZAG Formal analysis: MWM Investigation: MWM, AHB & ZAG Methodology: MWM, AHB & ZAG Project administration: MWM, AHB & ZAG Resource: MWM, AHB & ZAG Supervision: MWM, AHB & ZAG Validation: MWM, AHB & ZAG Visualization: MWM, AHB & ZAG Writing: original draft: MWM Rewriting: review and editing: MWM, AHB & ZAG.

Funding

No funding available.

Data availability

The manuscript primarily contains result-based data. For further requirements, complete data and additional materials related to the manuscript, please contact the corresponding author with a formal request via email: melakuwalelign25@gmail.com.

Declarations

Ethics approval and consent to participate

Ethical approval was obtained from the Institutional Review Board (IRB) of Debre Berhan University AWHSC School of Public Health Ethical Committee (Ref. No: IRB 01/60/2016). A formal permission letter was obtained from the administrative bodies of each selected health facility to access the records of the study participants. Informed consent from patients was obtained only for those who participated in the qualitative interview since quantitative information was gathered retrospectively from their medical records. To ensure confidentiality, the identities of all participants were kept anonymous, and all data collected was treated with strict confidentiality. The research was conducted in accordance with the Declaration of Helsinki.

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.