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. Author manuscript; available in PMC: 2013 Sep 1.
Published in final edited form as: Nurs Res. 2012 Sep-Oct;61(5):353–362. doi: 10.1097/NNR.0b013e31825fe3ef

Impact of a Rural Village Women (Asha) Intervention on Adherence to Antiretroviral Therapy in Southern India

Adeline Nyamathi 1, Alecia Y Hanson 2, Benissa E Salem 3, Sanjeev Sinha 4, Kalyan K Ganguly 5, Barbara Leake 6, Kartik Yadav 7, Mary Marfisee 8
PMCID: PMC3509934  NIHMSID: NIHMS399180  PMID: 22872107

Abstract

Background

Despite the increased prevalence of HIV in the rural female population of India, adherence to antiretroviral therapy continues to be low due to several barriers which discourage rural women.

Objectives

To assess the effectiveness of an intervention (Asha-Life) delivered by Accredited Social Health Activists to improve antiretroviral therapy adherence of rural women living with AIDS in India compared to that of a usual care group.

Method

A total of 68 rural women living with AIDS, aged 18–45 years, participated in a prospective, randomized pilot clinical trial and were assessed for several factors affecting adherence, such as sociodemographic characteristics, health history, CD4 cell count, enacted stigma, depressive symptomology, help getting antiretroviral therapy, and perceived therapy benefits.

Results

Findings at 6 months revealed that, while both groups improved their adherence to antiretroviral therapy, there was greater improvement in the Asha-Life group (p < .001), who reported a greater reduction in barriers to antiretroviral therapy than those in the usual care group.

Discussion

Antiretroviral therapy adherence showed significant increase in the Asha-Life cohort, in which basic education on HIV/AIDS, counseling on antiretroviral therapy, financial assistance, and better nutrition was provided. The Asha-Life intervention may have great potential in improving antiretroviral therapy adherence and decreasing barriers among rural women living with AIDS in India.

Keywords: HIV/AIDS, antiretroviral therapy, adherence, rural women, India

Approximately 2.47 million people in India are infected with the HIV; about 40% of these people are women (National AIDS Control Organisation [NACO], 2010; Pandey et al., 2009). In addition, HIV prevalence continues to rise among women (Kodandapani & Alpert, 2007) shifting from urban to rural India (Pallikadavath, Garda, Apte, Freedman, & Stones, 2005; Sinha et al., 2008). The majority (87%) of HIV infection in Indian women is due to heterosexual transmission from a partner with whom the women have a monogamous relationship (NACO, 2010). Consistent adherence to antiretroviral therapy (ART) of 95% or greater is necessary to suppress viral load and prevent drug resistance (Ajithkumar, Neera, & Rajani, 2011; Krakovska & Wahl, 2007; Nischal, Khopkar, & Saple, 2005), but a number of factors discourage women in India, particularly rural women, from remaining adherent to ART.

Barriers Impacting Adherence

Rural women report multiple factors that impact their adherence to ART. These factors include having little to or no access to HIV/AIDS facilities or government programs since HIV-related visits require traveling a great distance into the city, where government hospitals are located (Ghosh, Wadhwa, & Kalipeni, 2009). From 2004 to 2009, free ART centers increased from 8 to 230 public health facilities; however, almost all of these facilities are in urban settings (Bachani et al., 2010). Because all patients with AIDS in India receive ART in 30-day allotments, a visit every month is required, necessitating monthly travel to government district hospitals (Bachani et al., 2010). In a study of three large tertiary care ART facilities in India, as many as 63% of patients receiving ART resided outside the treatment district (Bachani et al., 2010). Traveling a long distance to receive ART monthly is problematic for women, as they are responsible for taking care of their children, are in need of childcare (Sharma et al., 2007), and are often ill themselves (Nyamathi, Sinha, et al., 2011; Nyamathi, William, et al., 2011). Furthermore, in a study of rural women living with AIDS, Nyamathi, Sinha, et al. (2011) reported that the women also chose not to visit the district hospital if they had visitors in their homes.

Lack of funds to purchase ART may also serve as a barrier to ART adherence by women who choose to go to private hospitals for care, especially when family funds have been depleted by their husband’s prior illness (Pallikadavath et al., 2005; Sharma et al., 2007; Tarakeshwar et al., 2006). In addition, psychological factors, such as depression, lack of social support, stigma, and poor coping behaviors also are associated with poor adherence to HIV/AIDS medication (Sarna et al., 2008; Tarakeshwar et al., 2006).

In terms of perceived benefits of taking ART in resource-limited settings (Fox et al., 2010) and (Chakrapani, Newman, Shunmugam, Kurian, & Dubrow, 2009) revealed that HIV-positive persons’ fear of discrimination by others affected their perceptions of ART benefits. Moreover, negative experiences with healthcare providers also were common. Low perceived benefits of ART also may be related to lack of adequate counseling and knowledge of ART, lack of time to visit clinics to take ART, difficulty in travelling to the clinic, and side effects of ART (Nyamathi, Sinha, et al., 2011). Several individual-level and family-level barriers also have been observed; these barriers included lack of family support to initiate and continue ART (Nischal et al., 2005), lack of adequate food and proper nutrition (Tang et al., 2011) to take ART, and preference for traditional homeopathic medicine over ART (Fritts et al., 2008).

Outcomes of Treatment Programs

While almost no studies have been conducted with rural women living with AIDS in India, in a study of people (n = 927) with AIDS (34% female) attending ART hospitals in Hyderabad, Mumbai, and Chennai, 13% of patients died within a 2-year span (Bachani et al., 2010). Furthermore, over one-third (35%) of patients in that study failed to pick up their monthly drugs on at least one occasion within 2 years, with increased occurrence in the second year. Even when ART is purchased, adherence and viral suppression may be minimally improved. For example, in a private clinic in Mumbai, 73% of patients who paid for their ART had 95% adherence in the past four days; however, only 46% showed viral suppression, indicating poor long-term adherence (Shah et al., 2007). Likewise, in a longitudinal assessment of a large hospital located in New Delhi, at 3-year follow-up, only about half (344) of the initial 631 enrolled HIV-positive patients were still seeking ART (Sharma et al., 2010).

Given the high prevalence of people living with AIDS who are not adherent to ART, interventions to assess the efficacy of strategies designed to improve adherence and reduce the barriers that women face in adhering to ART are critical. The purpose of this study was to assess the effectiveness of an intervention delivered by Ashas (Accredited Social Health Activists), who are trained lay village women, in improving adherence and reducing barriers to ART among rural women living with AIDS in India.

Method

Design

A total of 68 rural women living with AIDS participated in a pilot of a prospective, randomized clinical trial designed to determine the impact of having HIV-trained village women, Ashas, participate in the care of these women, along with other healthcare providers, compared to usual care. Human Subjects Protection Committee clearances were obtained in the US, and in India, ethical clearance was obtained through the Indian Council for Medical Research. Data collection began in August 2009 and ended March 2011.

Sample and Setting

Inclusion criteria for the study were: (a) women living with AIDS between the ages of 18–45 years; and (b) screened as receiving ART for at least 3 months. An exclusionary factor was CD4 cells less than 100, because these women were extremely frail and generally not able to participate in the program. Two high prevalence major HIV/AIDS villages or mandals in rural Andhra Pradesh were selected randomly from 16 major villages that were demographically alike in terms of HIV prevalence of 2% and served by a distinct Public Health Center. Among the two villages, the first one randomly selected was assigned to engage the intervention group, and the second engaged the usual care group. The distance from the intervention village to the district hospital is approximately 24 miles and the control village was 28 miles. Public transportation in the form of bus or auto rickshaw were options for the women.

In total, 91 women were screened; 23 were not eligible due to not being on ART or having CD4 levels less than 100. The remaining 68 were enrolled into the study (See Figure 1 for CONSORT diagram). The majority of women in the control (64%) and intervention (79%) groups were on a regimen of stavudine (D4T), lamivudine (3TC), and niverapine (NVP); fewer of the women in the intervention group (21%) compared to the control group (40%) were on D4T + 3TC + efavirenz (EFV) or zidovudine (ZDV) + 3TC, respectively.

Figure 1.

Figure 1

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CONSORT Diagram

Comprehensive Health Seeking and Coping Model

A modified version of the Comprehensive Health Seeking and Coping Paradigm (CHSCP; Nyamathi, 1989) served as the theoretical framework for the intervention study. The framework originated from the Lazarus and Folkman (1984) Stress and Coping Model and the Schlotfeldt (1981) Health Seeking Paradigm. The CHSCP has been applied to investigations focused on understanding HIV, hepatitis, and tuberculosis risk and protective behaviors and health outcomes (Nyamathi, Berg, Jones, & Leake, 2005; Nyamathi, Christiani, Nahid, Gregerson, & Leake, 2006; Nyamathi et al., 2002) among homeless and impoverished women and men.

The CHSCP is composed of a number of antecedent, mediating, and dependent variables (Figure 2). The antecedent variables include sociodemographic factors and health history, which includes age, education, religion, and health care history (CD4 cell count, length of time since HIV diagnosis) and health care access and utilization (number of visits to receive health care). Mediating components include situational, personal, social, and cognitive factors, and health seeking and coping behaviors. Modifications for this study included incorporating AIDS-related measures as part of situational factors (enacted stigma experienced), personal factors (depressive symptoms), resources (help getting ART), cognitive factors (perceived ART barriers and benefits of ART), and health seeking and coping behaviors (taking their ART medication). The dependent variable in this study was adherence level to ART.

Figure 2.

Figure 2

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Comprehensive Health Seeking and Coping Paradigm

Procedure

Preparing Ashas and finalizing the intervention

The research team was composed of two U.S. investigators and two Indian investigators; the latter included a medical doctor and a social scientist. Formative research was conducted to lay the groundwork for the intervention study and assess the needs and strategies of the intervention implementation from the perspective of the women living with AIDS, HIV rural physicians and nurses, and reproductive health-focused Ashas (Nyamathi, Sinha, et al., 2011; Nyamathi, William, et al., 2011). Based on findings from the formative phase, the research protocol and an operational manual were finalized, and training of nurses, physicians, and Ashas was undertaken by the study investigators and project director.

Nurses and physicians in both Public Health Centers received updated information about HIV and AIDS and clinical progression, as well as updates on ART protocol and dosage and the side effects of ART. Moreover, information about the study and the role of the healthcare providers in delivering appropriate symptomatic care to the participants was presented. This training lasted 1 day. In addition, the research physician, who was located in a nearby nonstudy site, examined the women living with AIDS monthly to conduct health assessments, such as weight and BP, and inquired about side effects. Referrals to medical and psychiatric healthcare providers were provided as necessary.

Lay village women who were trained as Ashas for the intervention group were selected by the project director among women who responded to an advertisement for this position. Women were selected if they were educated beyond high school, were interested in caring for women living with AIDS, and lived in the same village as the women who participated. Once selected, these intervention Ashas (n = 4) were trained by the project director, physician, social scientist, investigators, and local research physician over a 3-day period. A similar process for selection was undertaken for 2 control Ashas who were trained to function as basic community workers.

The content provided to the experimental Ashas included: (a) review of the study and manual forms; (b) understanding the needs of women living with AIDS, as discovered in formative research; (c) basics of HIV/AIDS and progression; (d) importance of adherence to ART; (e) coping strategies for dealing with distress brought on by HIV/AIDS; (f) importance of nutrition in improving the lives of women living with AIDS and their families; (g) life skills options and how to integrate them into the lives of the women; and (h) understanding the role of the Ashas in implementing the intervention study. The content provided to the control Ashas included the first four items above, as well as understanding their role in implementing the standard study. In addition to the didactic sessions, all Ashas were observed within trainer-conducted mock intervention sessions. Supervision was ongoing.

Enrolling participants

The study was announced in each Public Health Center by means of flyers posted in the large waiting area where patients collected. As the participants spoke only Telegu, the Human Subjects Committee approved versions of the flyers, informed consents and questionnaires in the Telegu language. Such documents were translated from English to Telegu and then verified in Telegu by a native speaker. Telegu was also the language that the classes were delivered in both programs. Participants interested in the study contacted the project director for further information about the study. After a more detailed description was provided, and all questions were answered, interested women signed the first informed consent, which enabled the project director to administer a brief 2-minute structured questionnaire to inquire about age, education, and other sociodemographic and health characteristics, including HIV and ART status. All of these questions were used to determine eligibility for the study and provided basic sociodemographic information on those not eligible.

If eligibility was met, the project director discussed the need for testing CD4 levels and a second informed consent was signed, followed by a venipuncture in the Public Health Center. Within 4 days, the women met with the project director to discuss the test results, and if the CD4 cells were not less than 100, the final informed consent was signed and the baseline questionnaire was administered. The women were then signed up for the intervention to begin. All respondents were paid $5 for completing the screening procedures, $10 for returning for test results and completing the baseline questionnaire (same day), $10 for each session, and $20 upon completion of the 6-month questionnaire.

Asha-Life Intervention

The participants who were randomized to the Asha-Life intervention received six program-specific group classes in sequence: (a) HIV/AIDS and dealing with the illness; (b) learning about ART and ways to overcome barriers; (c) parenting and maintaining a healthy home environment; (d) how to improve coping, reduce stigma, and care for family members; (e) basics of good nutrition and easy cooking tips; and (f) benefits of engagement in a life skills class, such as computer skills, marketing, and embroidery. In addition, the women living with AIDS received monthly supplies of 1 kg of urad dal (black gram) and 1 kg of toor dal (pigeon pea).

The primary role of the intervention Ashas was to visit the 4–5 women assigned to them weekly, monitor barriers to ART adherence, and provide assistance to mitigate any barriers they faced in accessing health care or the prescribed treatment. Assistance included accompanying the women to the district hospital or to the psychologist, and counseling them about coping strategies to deal with side effects and discrimination. The intervention Ashas were trained to inquire about side effects, provide basic education and counseling, promote healthy lifestyle choices, and link women living with AIDS to community resources to match health needs.

Usual Care Program

The usual care participants received six group classes matched in terms of number and length of time to those of the intervention program. The usual care sessions generally included the first three topics described for the intervention program. In this program, which served as the control program, the group classes included the importance of maintaining adherence to the ART, keeping healthcare appointments, and nutrition. The women received monthly supplies of yellow chana dal (chickpeas) in an effort to address malnourishment. They also received basic nutrition supplementation in the form of chana dal (black chickpeas) due to their poor nutritional status in general. The usual care Ashas did not assist women living with AIDS to get to the government hospital or to overcome barriers to care. The primary role of these Ashas was to visit the 8–10 women assigned to them weekly, monitor barriers to ART adherence, inquire about side effects, and provide basic education. They were not trained to fill the same supportive role as the intervention Ashas.

Measures

Several of the instruments have been tested previously with women living with AIDS in the US (Rotheram-Borus, 2000; Rotheram-Borus, Stein, & Lin, 2001; Whitbeck, Hoyt, & Bao, 2000) and in India (Ekstrand, Chandy, Gandhi, Stewart, & Singh, 2006). All instruments were administered at baseline and at 6-month follow-up unless noted differently.

Sociodemographic information

Information was collected using a structured questionnaire that included age, birthday, education, relationship status, and number of children.

Health history

Self-reported information on HIV-related physical symptoms, treatment history, and barriers and facilitators to adherence was collected. Also assessed was history of psychiatric diagnoses and treatment and healthcare access and utilization.

CD4 cell count

The CD4 counts were assessed at baseline. Blood samples were sent to the designated lab for CD4 determination by flow cytometry. The absolute numbers of CD4 were obtained by multiplying percentage from flow cytometry by total white blood cell count (determined by the COULTER AcT diff Analyzer, Beckman Coulter, Brea, CA).

Enacted stigma

This measure of stigma is used to assess whether participants have experienced specific discriminatory acts due to their HIV infection, such as being forced to move out of their home. Ten items in this scale were used to measure enacted stigma using a yes or no format. This set of items was developed by Ekstrand, Bharat, Ramakrishna, and Heylen (2011) based on previous research (Berg & Arnsten, 2006). The items were modified based on qualitative interviews conducted in India (Bharat, Aggleton, & Tyrer, 2001; Steward et al., 2008). An example of an item in this scale is: “Have you been told not to share your food or utensils with your family because of your HIV?” Reliability for the scale was .90 in this sample.

Depressive symptomatology

The CES-D is a 20-item scale used to measure frequency of depressive symptoms on a 4-point continuum. The CES-D has well-established reliability and validity. Scores on the CES-D range from 0–60, with higher scores representing greater depressive symptomatology. A score of 16 or greater suggests a need for psychiatric evaluation of depression (Radloff, 1977). Women having higher scores in this sample were referred to as having depressed mood. Internal consistency for the CES-D scale in this sample was .94.

Help getting antiretroviral therapy

Eight questions were used to determine whether specific people helped the women get their HIV medication; possible people were spouse, siblings, parents, and children. Participants were asked to respond yes or no as to whether each type of person helped them to get their HIV medication. A summary-derived variable was assigned a score of 1 if at least one of the people listed had assisted with the provision of HIV medication and 0 if no one had assisted.

Perceived antiretroviral therapy benefits

Fifteen items with yes or no responses were used to ask participants whether they had experienced each particular benefit. Items included You have a better appetite, You don’t get sick as often, and You enjoy your social life more. An overall benefit score was assigned a value of 1 if the women reported at least one ART benefit and 0 if no ART benefits were reported.

Barriers to HIV medication adherence

Developed from focus group interviews in India with people living with AIDS (Ekstrand et al., 2006), 18 items were constructed to inquire about factors that sometimes cause people to miss taking their HIV medications. These were summed into four indices: Lack-of-routine-related barriers included disruption of daily routine, forgetting to take the medicine, and being away from home or busy with other things. Refill-related barriers included running out before being able to get a prescription refill, pharmacy stock-outs, lack of money for refills, and avoiding getting medication in the woman’s home town for fear of disclosure. Health-related barriers included missing pills because of being sick, depressed, or drinking alcohol; or feeling healthy enough to skip medication. Regimen-related barriers assessed if participants had missed doses because they felt the medication was harmful, had problems following specific regimen instructions (e.g., when to take the pills), or wanted to avoid side effects. The responses were measured on a 4-point Likert scale that ranged from 0 = never to 3 = most of the time. The 18 items formed a scale with a reliability of .95. A mean-item scale was constructed for analysis.

Adherence

Observation by pill count was used to measure adherence by the interviewer who visited the home of each client during the 3-day baseline procedure period. Adherence was calculated based on the number of pills consumed during the baseline month divided by the number of pills prescribed per month.

Data Analysis

Initial analyses examined whether the two programs were comparable on important baseline variables; these analyses included chi-square tests for categorical variables and two-sample t-tests or Wilcoxon tests for continuous variables, depending on the underlying distributions. Simple changes in adherence and barriers to ART between baseline and 6 months were then examined for baseline variables that differed between the two programs at the .15 level using t-tests and correlations. Change in adherence for the intervention program compared to that for the control program was assessed by multilevel linear regression analysis on the monthly adherence data (Figure 3). The differential rate of change in adherence between baseline and month 6 for the two programs was obtained from the program-by-time interaction. Variables that differed between the two programs at baseline at the .15 level and also were associated with the difference in adherence between 6 months and baseline at the .10 level were covariates in the model. For example, in an effort not to miss any important variables, a significance level of p = .15 was used for the group comparisons because the sample size of 34 women in each group was small. Once variables that might have been confounders had been identified, a more conservative p = .10 level was used to assess associations with change in adherence and barriers to reduce the likelihood of overfitting regression models.

Figure 3.

Figure 3

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Adherence to Antiretroviral Therapy Among the Asha Sample

With respect to barriers to ART, standard linear regression modeling on the difference between barriers at baseline and 6 months was used to assess whether there was an important program effect on change in barriers to ART. Potential confounders that differed between programs at baseline and were related to change in barriers, as described for the adherence analyses, were controlled. Covariates in the models for both outcomes were examined for multicollinearity, which was not a problem.

Results

Sociodemographics

A total of 68 women participated in the study, with an equal division of 34 women in both the intervention and usual care programs. All participants completed the 6-month follow-up. Over half the women living with AIDS were married (52%) and two-thirds were Hindu (66%; Table 1). While over 1 in 5 women reported completing at least 4 years of school, women in the intervention group were more likely to complete 4 years compared to those in the usual care group (32% vs 12%, p < .05).

Table 1.

Sample Characteristics by Program and Overall (n = 68)

Baseline Variable Intervention Group Usual Care Group Total
n % n % % p
Any Children 32 94.1 27 79.4 86.8 .74
Married 15 44.1 20 58.8 51.5 .225
At Least 4 Years of School 11 32.4 4 11.8 22.1 .041
Hindu Religion 15 45.5 29 85.3 65.7 .001
More than 47 Months since HIV diagnosis 22 66.7 11 32.4 49.3 .005
Any Help Getting ART* b 16 47.1 9 26.5 36.8 .078
Any Perceived ART Benefit 20 58.8 27 79.4 69.1 .066
Depressed Mood c 24 70.6 13 38.2 54.4 .007
Baseline Variable (Range) M SD M SD M
Age, in years (20–45) 32.3 5.3 30.1 5.2 31.2 .102
CD4 Level (127–1071) 439.1 217.6 447.5 260.0 443.3 .885
Months Taking ART (0–86.8) 25.6 20.5 19.1 13.8 22.3 .126
Visits Past 3 Months (2–15) 7.7 3.5 7.4 3.6 7.5 .732
Enacted Stigma (0–10) 6.4 3.6 7.9 2.5 7.1 .056
Adherence to ART (22–88) 41.7 9.5 54.9 16.9 48.3 .001
Barriers to Adherence (0–27) 0.8 0.6 1.0 0.8 0.9 .149
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Notes.

*

ART+ Anti-retroviral therapy

a

Chi-square or t-test for program differences;

b

Help from family and friends

c

Based on a Center for Epidemiologic Studies Depression Scale score of 16 or greater

In terms of AIDS-related sociodemographics, about half had been living with AIDS for almost 4 years, with the intervention women living with AIDS the longest (p < .001). About one-third of the women living with AIDS reported receiving help from family or friends getting their ART. Slightly more than two-thirds perceived at least one benefit to taking ART.

The mean age of the sample was 31 years (± 5.3). Mean adherence scores at baseline were 41.7 for the intervention vs. 54.9 for usual care, and the difference was significant. No group baseline differences were found with respect to barriers to ART adherence, months taking ART, or visits to healthcare providers in the past 3 months. No differences were found in terms of CD4 levels as well. As shown in Figure 2, there was improvement in monthly measures of ART adherence for both programs, with improvement for the intervention program being particularly pronounced.

Benefits and Barriers to Taking Antiretroviral Therapy

Just over one-third of the women reported a number of benefits to taking ART. These included greater ability to work around the house (40%) and care for children (38%). Having a better appetite and feeling more alert and more energetic were reported by 38% of the sample (Table 2). However, as presented in Table 3, a number of barriers were experienced in getting or taking ART. Over half (53%) of the women reported running out of medication as a barrier to compliance, half reported feeling sick and wanting to avoid side effects, and just under half (46%–49%) reported feeling the medication was harmful, being asleep at the time of dosing, or being too busy. Additional barriers included not following a usual daily routine and forgetting (43%), not wanting to take medications in public (41%), and being away from home (38%).

Table 2.

Perceived Antiretroviral Therapy Benefits Endorsed by One-Third or More at Baseline (n = 68) by Group

Benefits Intervention
Group		 Usual Care
Group		 Total
n (%) n (%) n (%)
More able to work around house 15 (44.1) 12 (35.3) 27 (39.7)
More able to care for children 14 (41.2) 12 (35.3) 26 (38.3)
Have a better appetite 11 (32.4) 15 (44.1) 26 (38.2)
Feel more alert 9 (26.5) 17 (50.0) 26 (38.2)
Feel more energetic 10 (29.4) 13 (38.2) 26 (38.2)
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Table 3.

Ten Most Commonly Experienced Barriers to Antiretroviral Therapy at Baseline (n = 68) by Group

n % n % n %
Ran out of medication 17 (50.0) 19 (55.9) 36 (52.9)
Felt Sick 15 (44.1) 19 (55.9) 34 (50.0)
Wanted to Avoid Side Effects 13 (38.2) 21 (61.8) 34 (50.0)
Too busy with other things 16 (47.1) 17 (50.0) 33 (48.5)
Were asleep at medication time 18 (52.9) 15 (44.1) 33 (48.5)
Felt Medication was harmful 11 (32.4) 20 (58.8) 31 (45.6)
Not following normal daily routine 11 (32.4) 18 (52.9) 29 (42.7)
Forgot 13 (38.2) 16 (47.1) 29 (42.7)
Didn’t want to take medication in public 12 (35.3) 16 (47.1) 28 (41.2)
Were away from home 12 (35.3) 14 (41.2) 26 (38.2)
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Potential Confounders

Improvements in adherence to ART and barriers to taking ART as a function of program and a number of variables that differed between the programs at baseline are shown in Table 4. Program participation had the strongest and most consistent associations with improvement in adherence and barriers to ART. Participants in the intervention program had a much greater gain in adherence to ART and a greater reduction in barriers to ART than those in the usual care group, for whom barriers increased on average. However, not being Hindu was associated with positive change in both adherence and barriers to ART. While getting medication assistance from family and friends, not having any barriers to getting or taking ART and having no perceived benefits from taking ART were related weakly to adherence improvement (p < .10), improvement in barriers was related highly to not perceiving any benefit from taking ART and depressed mood at baseline. Additionally, improvement in adherence to ART was related to living with AIDS for over 47 months.

Table 4.

Associations of Selected Variables with Change in Adherence and Barriers

Adherence Changea Barrier Changeb
Baseline Variable Mean SD Mean SD
Program
 Intervention 57.6 9.2*** 0.74 0.6***
 Usual Care 5.7 20.9 −0.42 0.6
Children
 Yes 32.6 32.5 0.25 0.8*
 No 25.9 14.5 −0.43 0.8
4+ Years of School
 Yes 40.9 24.5 0.18 0.8
 No 29.1 31.9 0.15 0.9
Hindu Religion
 Yes 24.2 30.0** −0.05 0.9**
 No 44.5 27.6 0.53 0.6
Helpc Getting Medicine
 Yes 39.4 21.3+ 0.08 0.6
 No 27.2 34.5 0.21 0.9
Any Perceived ART Benefit
 Yes 27.6+ 28.4+ −0.09 0.7***
 No 40.9 34.3 0.71 0.9
More than 47 Months Since HIV Diagnosis
 Yes 40.0 25.3* 0.26 0.7
 No 22.6 33.1 0.04 0.9
Depressed Moodd
 Yes 36.4 34.6 0.45 0.7**
 No 26.0 24.6 −.0.19 0.9
Barrier to Medication Adherence
 Yes 24.1 37.3+ -- -- -- --
 No 38.4 21.8 -- -- -- --
Enacted Stigma ≥ 8.5e
 Yes 26.4 35.8 0.26 0.9
 No 37.0 23.9 0.05 0.8
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Notes.

a

6 months - baseline

b

baseline - 6 months

c

from Family and Friends

d

CES-D > 16

e

range = 0–10, median = 8.5

*

p < .05,

**

p < .01,

***

p < .001,

+

p < .10

Multivariate Analyses

In the multilevel linear regression analysis for the monthly adherence data, controlling for Hindu religion, help from family and friends in getting medication, time since HIV diagnosis, perceived ART benefit, and having at least one barrier to medication adherence, a significant time by program interaction effect (p < .001) was found. In subsequent analyses within each group for time effects alone, adherence was found to improve for both groups (p < .001).

An ordinary least squares regression model for change in barriers between baseline and 6 months, controlling for having children, Hindu religion, any perceived benefit of ART, and number of baseline barriers showed a significant effect for the intervention program (p < .001). Baseline barriers were associated strongly with barrier reduction (p < .001). The r-square for the regression model was .86. Additional paired t-tests showed a significant (p < .001) decline in barriers among the intervention participants from 0.80 at baseline to 0.06 at 6 months and a significant increase (p < .001) among usual care participants from 1.04 at baseline to 1.46 at 6 months.

Discussion

Findings of the pilot randomized trial revealed a distinctly greater improvement in ART adherence among the intervention participants compared to those in the usual care group. Moreover, the intervention cohort reported a significant reduction in barriers to ART. These findings probably reflect the multidimensional framework of the CHSCP that guided the very comprehensive program-specific intervention and support that the intervention Ashas provided. Asha support included weekly visits to the homes of the women living with AIDS to monitor barriers to ART adherence and to accessing regular care, and working diligently with the women to remove barriers (such as accompanying them to the hospital when ill) and to allow them to remain on ART consistently and to obtain needed treatment. Improvement in ART adherence to a lesser extent was observed in the usual care group as well, most likely as a result of the basic education provided, having a village woman inquire about their health, and the provision of some protein supplements.

The average ART compliance for the sample was 48.3 at baseline. This low compliance rate may have resulted from the fact that a minority of women perceived benefits to taking ART, such as feeling more energetic, having a better appetite, or being more able to care for their children. However, at 6 months, the intervention group had sustained ART adherence nearing 100%. Intervention Ashas were trained to educate women about the importance of strict adherence to ART. Having personal beliefs about the benefits of ART is important; being on ART longer than 2 years negatively affects ART adherence rates (Andreo et al., 2001). Therefore, women living with AIDS who feel they benefit from ART most likely will remain adherent longer than those who lack such a perception.

Several researchers have noted that lack of funds to purchase ART may serve as a barrier to ART adherence (Kumarasamy et al., 2005; Paranthaman, Kumarasamy, Bella, & Webster, 2009). In a qualitative study among HIV positive men and women (n = 60) in Chennai, India, Kumarasamy et al. (2005) found that a frequently cited barrier to ART was cost. While financial support is essential for optimal adherence for persons living with AIDS (Nischal et al., 2005), the women in this study had access to free ART at the government district hospital. However, having free medications does not necessarily result in improved adherence (Sarna et al., 2008). In fact, in one study in Pune and Delhi, participants who received free ART reported lower levels of adherence than those who needed to purchase their ART (Sarna et al., 2008).

Despite free medication, the cost of transportation for a bus trip that took hours and the difficulty to find childcare were exhaustive for many of these women and resulted in an inability to visit healthcare facilities. Because intervention Ashas provided bus fare to the intervention women, this may have contributed to improved adherence and decreased barriers to care, while the usual care participants did not receive support to visit the free district hospital for ART or care. Furthermore, the more accessible private clinics and hospitals were not available to rural women in general as cost was a prohibitive factor. These considerations are validated by a study undertaken in Bangalore, India, which found that persons living with AIDS who earned between 5000–9999 rupees/month were more likely to adhere to their medication compared to their counterparts who were less wealthy (Cauldbeck et al., 2009).

Improvement in cognitive factors, such as barriers to ART, was highly related to not perceiving any ART benefits initially. It is possible that women living with AIDS who perceived no benefits to ART at baseline may have changed their attitudes once enrolled in the program compared to those who did perceive benefits to taking ART. One role of the Ashas was to educate and counsel the women about the benefits of ART. Moreover, the fear of side effects has been found by other researchers to affect compliance with ART (Tarakeshwar et al., 2006). In one study, it was found that the milder the side effects to ART, the better the compliance (Cauldbeck et al., 2009). In the Asha-Life intervention, frequent discussions about the benefits of taking ART, plus the group classes to focus on side effects likely to occur and what to do about them, appeared to have been beneficial.

Finally, the finding that women living with AIDS with depressed mood at baseline had a greater reduction in barriers over time when compared to those with better emotional health is supported by other studies (Nischal et al., 2005; Sarna et al., 2008). It is possible that when psychological support is offered and facilitated, major barriers for seeking and accepting care are lifted. Ongoing focused studies are needed to investigate these changes.

Limitations

This study was limited by a small sample size from only two rural districts in south India. However, the findings may be applicable to other rural women living with AIDS in India since Andhra Pradesh is a large rural state with a significant population of HIV-infected women. Therefore, the findings may be generalizable to a larger cohort with similar population characteristics. In addition, despite the fact that the prevalence of HIV was similar across both study sites, the randomization of these two major villages did not result in equitable baseline variables with a number of variables. However, all variables that differed at baseline were controlled for in the regression analyses. An additional limitation is that with only two study sites, the differences seen may be because the sites differed in a systematic way.

Conclusions

The findings of this study lay the groundwork for a critical research trajectory related to the benefits of utilizing a multidimensional intervention, guided by theory in the training and engagement of Ashas in rural India in an effort to improve ART adherence and decrease barriers to adherence and care among women living with AIDS. Specifically, while rural women in India face significant and pronounced challenges in maintaining their health, and managing HIV/AIDS, Ashas provide a unique service delivery model that enables the development of support for marginalized and disenfranchised populations heavily impacted by HIV/AIDS. Clearly, the Asha-Life intervention has the potential to improve adherence among women living with AIDS in rural India. Future studies are needed to continue to validate these benefits in other populations of women living with AIDS in India and to expand investigations to the family as a unit.

Acknowledgements

Funding provided by the National Institute of Mental Health, Grant #MH82662.

Footnotes

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Contributor Information

Adeline Nyamathi, Distinguished Professor and Associate Dean for International Research and Scholarly Activities, School of Nursing, University of California, Los Angeles, Los Angeles, California.

Alecia Y. Hanson, School of Nursing, University of California, Los Angeles, Los Angeles, California.

Benissa E. Salem, School of Nursing, University of California, Los Angeles, Los Angeles, California.

Sanjeev Sinha, All India Institute of Medical Sciences, New Delhi, India.

Kalyan K. Ganguly, Indian Council for Medical Research, New Delhi, India.

Barbara Leake, School of Nursing, University of California, Los Angeles, Los Angeles, California.

Kartik Yadav, School of Nursing, University of California, Los Angeles, Los Angeles, California.

Mary Marfisee, School of Nursing Health at the Union Rescue Mission Center, University of California, Los Angeles, Los Angeles, California.

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