Provocative findings from a transdiagnostic counseling intervention to improve psychiatric comorbidity and HIV care engagement among people with HIV: A Pilot Randomized Clinical Trial

Abstract

Background:

Depression, anxiety, post-traumatic stress (PTS), and alcohol/substance use disorders are prevalent among people with HIV (PWH), commonly co-occur, and predict worse HIV care outcomes. Transdiagnostic counseling approaches simultaneously address multiple co-occurring mental health disorders.

Methods:

We conducted a pilot individually randomized trial of the Common Elements Treatment Approach adapted for people with HIV (CETA-PWH), a transdiagnostic counseling intervention, compared to usual care at a large academic medical center in the southern US. Participants were adults with HIV, at risk for HIV care disengagement, with elevated symptoms of depression, anxiety, PTS, and/or alcohol/substance use. Mental health and HIV care engagement were assessed at four and nine months.

Results:

Among participants (n=60), follow-up was high at four (92%) and nine (85%) months. Intervention engagement was challenging: 93% attended ≥1 session, 43% attended ≥6 sessions in three months (“moderate dose”), and 30% completed treatment. While not powered for effectiveness, mental health outcomes and HIV appointment attendance improved in CETA-PWH relative to usual care in intent-to-treat analyses; those receiving a moderate dose and completers showed progressively greater improvement. Viral load showed small differences between arms. The dose-response pattern was not explained by differences between those who did and did not complete treatment.

Conclusions:

This pilot trial provides preliminary evidence for the potential of CETA-PWH to simultaneously address co-occurring mental health co-morbidities and support HIV appointment attendance among PWH. Additional strategies may be an important part of ensuring that clients can engage in the full course of treatment and realize its full benefits.

Introduction

Depression, anxiety, post-traumatic stress (PTS), alcohol use, and substance use disorders, hereafter called common mental disorders, affect people with HIV (PWH) far more commonly than the general population.^1–9 Beyond these disorders’ morbidity and mortality, they consistently and strongly predict worse HIV care outcomes: reduced antiretroviral adherence and HIV care engagement, viral failure, and accelerated mortality.^10–38 Evidence-based treatment for these disorders improves HIV care outcomes^39–41 and, if implemented nationwide, would be expected to measurably improve national viral suppression.⁴²

Common mental disorders in PWH frequently co-occur,^4,6–9 commonly overlaid on a lifetime of exposure to traumatic experiences.^2,43 Among PWH, more than half of those with a depressive disorder also have at least one other common mental disorder. Addressing co-occurring disorders individually and sequentially is inefficient and less effective.^44–46

This psychiatric comorbidity highlights the relevance of transdiagnostic mental health treatment. Transdiagnostic approaches leverage commonalities in cognitive behavioral therapies to provide a unified, customizable framework for evidence-based treatment for any combination of common mental disorders.^47,48 Transdiagnostic approaches further provide a platform for directly supporting HIV medication adherence and engagement, by integrating cognitive behavioral therapy for depression and HIV care engagement which improves both outcomes.^41,49

Accordingly, we conducted a pilot randomized trial of an evidence-based transdiagnostic mental health intervention^47,50 which we previously enhanced and adapted to additionally support HIV care engagement⁵¹ among PWH with elevated common mental disorder symptoms. We hypothesized that the intervention would show preliminary evidence of impact on mental health and HIV care engagement outcomes.

Methods

Design

This study was a single-site individually randomized pilot trial comparing the intervention (transdiagnostic treatment) to enhanced usual care. This pilot trial was not powered for effectiveness but was designed to assess preliminary indicators of effectiveness for mental health and HIV outcomes.

Participants

Participants were recruited from a large academic Southern US medical center providing comprehensive HIV clinical and supportive services to ~4,000 patients annually. Eligible individuals were a new/current patient, had elevated mental health symptoms in ≥1 domain, and had ≥1 indicator of increased HIV care disengagement risk. Elevated mental health symptoms were indicated by ≥1 of elevated: depressive symptoms (Patient Health Questionnaire-9 (PHQ-9) ≥10); anxiety symptoms (Generalized Anxiety Disorder-7 (GAD-7) ≥10); PTS symptoms (PTSD Checklist for DSM-5 (PCL-5) ≥33); alcohol use (Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)-Alcohol ≥11); or substance use (ASSIST-Drug ≥4 for any individual substance: cannabis, cocaine, amphetamines, inhalants, sedatives, hallucinogens, or opioids). Increased risk of HIV care disengagement was indicated by ≥1 of: newly established HIV care, ^52,53 viral load >1,000 copies/mL, or ART regimen switch in the past 6 months; or any missed HIV primary care appointment in the past 12 months.^54–56

Eligible and willing individuals provided IRB-approved oral informed consent. Participants completed a baseline research interview before randomization. Due to COVID-19, participants received a tablet with an Internet data package to allow remote counseling and research contacts. Tablet functionality was restricted to only permit study and intervention contacts. Participants in both arms completed interviewer-administered research interviews at 4 and 9 months post-consent, receiving $50 per interview, with a research interviewer, not blinded to condition, with many years’ experience conducting behavioral research with this population. Nearly all research interviews (92%) and approximately three-quarters of counseling sessions were completed remotely.

Intervention

The intervention is an adaptation of the Common Elements Treatment Approach (CETA),⁵⁰ a flexible, transdiagnostic, and modular cognitive-behavioral therapy for common mental disorder symptoms. This study’s adaptation additionally addressed HIV treatment engagement and HIV-related stigma.⁵¹ CETA was originally developed to improve access to effective and readily implementable psychotherapeutic treatment for comorbid PTS, anxiety, and depression symptoms among trauma survivors in low- and middle-income countries. Subsequent CETA iterations incorporated alcohol use treatment.^57,58 CETA has demonstrated effectiveness for improving symptoms across all of these domains.⁵⁷

This study’s adapted version of CETA for people with HIV (CETA-PWH) incorporates principles of cognitive-behavioral therapy and measurement-based care, or the systematic evaluation of patient symptoms to inform treatment. The clinician uses standardized symptom assessments, patient goals, CETA training guidelines, supervisor consultation, and clinical judgment to determine which therapeutic components to deliver, in what order, and for how long. The therapist can deliver 13 potential components; the first two introduce patients to CETA-PWH and how the therapy will help their symptoms, and seek to enhance therapy engagement. Subsequent components teach patients cognitive and behavioral skills related to specific treatment goals. Additional components that address safety concerns are used as needed. The final component emphasizes lessons from therapy and plans for maintaining therapeutic gains.

In CETA-PWH, specific PWH needs were addressed with a component based on the Life-Steps intervention to promote HIV treatment engagement,^59,60 specifying how CETA-PWH skills could be utilized to promote HIV treatment engagement and reduce HIV-related stigma, and incorporating PWH-specific examples in therapy. CETA-PWH was expected to comprise 7–13 weekly sessions and conclude in ~4 months.

Two masters level social workers implemented the intervention: one medical case manager, and one therapist transitioning from medical case management to mental health counseling after completing a 9-month social work internship.

Intervention Training, Supervision, and Fidelity Monitoring

The interventionists completed 4 half-days of virtual workshop training led by a licensed clinical social worker with 10 years of clinical supervisory experience and 7 years of CETA training and consultation. An experienced Life-Steps supervisor led the Life-Steps training. The training utilized didactics, videos demonstrating CETA skills, practice selecting CETA-PWH treatment flows and clinical targets, and role-play.

Both counselors practiced CETA-PWH delivery with 1–2 training cases. Since no resulting substantive changes were made to CETA-PWH, the three training cases were included in the trial.

The CETA-PWH trainer supported counselors to deliver CETA-PWH with fidelity through biweekly supervision, reviewing case notes and discussing cases and intervention delivery in detail. At study conclusion, based on structured counselor session notes, case review during supervision, and audio recording of select sessions, the supervisor rated their confidence that each counselor was routinely administering each CETA module with high fidelity on a scale from 0 (“Not at all”) to 4 (“Completely”), rating those modules each counselor had experience delivering.

Comparison condition

Participants randomized to the comparison condition received enhanced usual care. The site’s usual mental health care includes referral to a clinic social worker or counselor or to an external mental health clinic as needed. Most mental health services provided onsite focus on short-term crisis management or substance use, or longer-term supportive counseling informed by cognitive behavioral therapy and related approaches. This study enhanced usual care by providing the participant’s medical provider in both arms with information about the participant’s elevated mental health symptoms and treatment recommendations.

Outcomes

For preliminary assessment of CETA-PWH effectiveness in this pilot trial, outcomes were mental health and HIV outcomes expected to be primary outcomes for a future large-scale trial. Since participants enrolled with different elevated mental health domains, the pre-specified primary mental health outcome, global symptom improvement, measured at 4 and 9 months, was defined as the average of the percent change (positive or negative) from baseline in all domains elevated for that participant at baseline (Supplement). For example, a participant enrolling with elevated PHQ-9, GAD-7, and PCL-5 scores, would have a global symptom improvement value of the average of the percent change in the PHQ-9, GAD-7, and PCL-5 scores from their respective baseline values. For participants with an elevated ASSIST-D score for multiple substances, we calculated change for the substance with the highest baseline score. We additionally defined global symptom response as ≥50% vs. <50% global symptom improvement.

As HIV outcomes, we evaluated HIV RNA viral suppression (<200 copies/mL, from the two viral loads closest to the 4-month and the 9-month time points in the medical record) and HIV appointment attendance over 12 months post-consent from the medical record. Appointment attendance was operationalized using the HRSA HAB measure (two HIV medical appointments ≥90 days apart in 12 months) and the kept visit proportion (number of kept visits divided by number of kept and missed visits).⁶¹

Sample size

This pilot trial’s goal was to provide preliminary evidence of the likely magnitude of intervention effect on mental health and HIV outcomes. The sample of 60 participants is sufficient to estimate intervention effect risk ratios with 95% CIs that are two- to three-fold wide (e.g., RR=1.7; 95%CI=1.1–2.5). The study was not powered to statistically detect intervention effects.

Randomization

The PI generated the randomization list using a STATA software package random number generator with blocks of size six. The randomization list resided in a protected folder restricted to the study PI and data manager. After each participant had completed enrollment and baseline data collection, the study coordinator contacted the data manager for the next randomization slot.

Statistical methods

To estimate preliminary effectiveness indicators, we completed three sets of analyses: intent-to-treat, moderate intervention dose, and intervention completer. Intent-to-treat analyses analyzed all participants according to the arm to which they were randomized. The moderate dose analysis compared the usual care arm to the subset of CETA-PWH participants who attended ≥6 sessions in the first three months after consent. The completers analysis compared the usual care arm to the subset of CETA-PWH participants who completed CETA-PWH. Participants were defined as completing CETA-PWH when the client and counselor agreed during counseling that the client had met their treatment goals and was ready to conclude treatment, and the supervisor concurred upon review with the counselor during supervision.

We compared outcomes between groups using mean differences for continuous variables and proportion differences for binary variables, with effect estimates and confidence intervals generated from linear or binomial regression models with treatment group as the sole explanatory variable. As this pilot trial was not designed to have statistical power to detect intervention effects, no statistical significance testing is reported.

While moderate dose and completer analyses, relative to ITT analyses, improve exposure classification by restricting analyses to those who received a moderate or full intervention dose, these non-randomized analyses risk confounding bias because of the potential for common causes of intervention engagement and outcomes. In sensitivity analyses, we used inverse probability weights to assess the validity of these analyses (Supplemental Materials).

Ethical approval and registry

This study was approved by the institutional review boards of the University of Alabama at Birmingham and the University of North Carolina at Chapel Hill and was registered at ClinicalTrials.gov prior to enrollment launch (NCT04163341).

Results

Participant flow

From October 2020-December 2021, 93 potentially eligible patients were approached of whom 60 were eligible, provided informed consent, and enrolled (Figure 1).

Figure 1.

CONSORT Flowchart

Sample

Participants had a mean age of 42 (standard deviation [SD]: 12) years and primarily identified as male (55%) or female gender (37%) (Table 1). Participants had generally lived with HIV for many years (mean 10 [SD: 9] years). On the PTSD Checklist of 15 potential lifetime traumatic experiences, participants had experienced a median of 6.5 (IQR: 4–10) traumatic experiences (SuppFigure S1). Compared to the clinic population overall, the enrolled sample was slightly younger (median 42 vs. 47 years) and had more females (37% vs. 24%).

Table 1.

Participant Baseline Characteristics, TRACE Study (n=60).

	Overall (N=60)	CETA (N=30)	Usual Care (N=30)
Age: Mean (SD)	41.9 (11.6)	39.8 (9.4)	44.0 (13.4)
Gender Identity
Male	33 (55.0%)	18 (60.0%)	15 (50.0%)
Female	22 (36.7%)	10 (33.3%)	12 (40.0%)
Transgender Male	1 (1.7%)	1(3.3%)	0 (0.0%)
Transgender Female	2 (3.3%)	1(3.3%)	1(3.3%)
Additional sex or gender	2 (3.3%)	0 (0.0%)	2(6.7%)
Racial group
White or Caucasian	10 (17.2%)	4 (13.3%)	6 (20.0%)
Black or African American	45 (75.0%)	22 (73.3%)	23(76.7%)
American Indian or Alaska Native	1 (1.7%)	1 (3.3%)	0 (0.0%)
Asian or Pacific Islander	1 (1.7%)	1 (3.3%)	0 (0.0%)
Other	3 (5.0%)	2 (6.7%)	1 (3.3%)
Hispanic or Latinx	2 (3.3%)	2 (6.7%)	0 (0.0%)
Sexual Orientation *
Heterosexual	31 (52.5%)	15 (51.7%)	16 (53.3%)
Gay	15 (25.4%)	10 (34.5%)	5 (16,7%)
Bisexual	8 (13.5%)	3 (10.3%)	5 (16.7%)
Other	5 (8.5%)	1 (3.5%)	4 (13.3%)
Years since HIV diagnosis: Mean (SD)	10.4 (9.4)	8.4 (8.1)	12.4 (10.3)
Currently employed	23 (38.3%)	13 (43.3%)	10 (33.3%)
Stable housing in past month	44 (73.3%)	22 (73.3%)	22 (73.3%)
Study eligibility criteria
Elevated mental health symptoms
Depressive symptoms: PHQ-9 ≥10	40 (66.7%)	21 (70.0%)	19 (63.3%)
Anxiety symptoms: GAD-7 ≥10	39 (65.0%)	20 (66.7%)	19 (63.3%)
PTSD symptoms: PCL-C ≥33	36 (60.0%)	20 (66.7%)	16 (53.3%)
Alcohol use: ASSIST-A ≥11	15 (25.0%)	9 (30.0%)	6 (20.0%)
Substance use: ASSIST-D ≥4	48 (80.0%)	23 (76.6%)	25 (83.3%)
Risk of poor HIV care engagement
HIV care began < 6 months ago	13 (21.7%)	7 (23.3%)	6(20.0%)
Viral load > 1000 copies/mL within past 6 months	30 (50.0%)	15 (50.0%)	15 (50.0%)
ART regimen changes within past 6 months	0 (0.0%)	0 (0.0%)	0 (0.0%)
No-showed for an HIV care appointment within past 12 months	31 (51.7%)	16 (53.3%)	15 (50.0%)

^*Missing sexual orientation for one participant

Although eligibility only required one elevated mental health domain, 62% exceeded the threshold on ≥3 domains. Depressive, anxiety and PTS symptoms were each above threshold in 60–67% of participants, whereas substance use and alcohol use were above threshold in 80% and 25% of participants, respectively (Table 1).

Participants met the HIV care engagement-related study eligibility criteria primarily because of either having had an HIV RNA viral load (VL) >1,000 copies/mL in the prior 6 months (50%) or having no-showed for at least one HIV care appointment in the prior 12 months (52%) (Table 1).

Demographic and eligibility characteristics were well balanced between arms.

Intervention delivery and engagement

For most clients, counselors reported two (43%) or three (46%) clinical targets for therapy (median: 2). The most common clinical targets were PTS (68%) and HIV treatment engagement (68%), followed by depression (42%), anxiety (36%), substance use (25%), and HIV-related stigma (9%).

Client session attendance and therapy completion varied greatly (SuppFigure S2). Of the 30 intervention participants, 28 (93%) attended ≥1 session, 13 (43%) received a moderate dose and 10 (33%) completed CETA. Completers attended a median of 18 sessions (range: 11–24) over 6 months (range: 4–9 months), while those who dropped out or stopped before completion attended a median of 4.5 sessions (range: 0–14) over 3 months (range: 0–9 months).

Counselors reported that clients completed a mean of 5.6 components. Engagement and psychoeducation were completed by all clients; other common completed components were Life Steps (89%), Thinking in a Different Way Parts 1 and 2 (57% and 32%, respectively), Relaxation (39%), and Problem Solving (25%).

Intervention arm participants utilized fewer non-study behavioral health services than usual care participants. Intervention participants attended an average of 0.9 mental health and 0.6 substance use treatment visits per person between enrollment and nine months, compared to 2.0 mental health and 1.8 substance use treatment visits per person in the usual care arm.

The supervisor’s overall fidelity rating across all modules and both counselors was 3.3 on the 0–4 scale (counselor 1: 3.3; counselor 2: 3.0), indicating that based on the information reviewed, the supervisor was “mostly” or “completely” confident that the counselors were administering the delivered components with high fidelity.

Outcomes

Research interview retention was 92% (55/60) at 4 months and 85% (51/60) at 9 months, and was balanced between arms. In the intent-to-treat analysis, participants randomized to CETA-PWH showed greater global symptom improvement compared to usual care at 4 months (mean difference −2.6% [95% CI: −22.3, 17.0]) and 9 months (MD −19.8% [−43.1, 3.5]) (Figure 2; SuppTable S1). Among those receiving at least a moderate dose, a larger benefit was observed relative to usual care at 4 months (MD −19.6 [−45.7, 6.4]) and 9 months (MD −26.0 [−57.9, 5.8]). Among those completing CETA, an even greater benefit was observed relative to usual care at 4 months (−24.0 [−52.3, 4.2]) and 9 months (MD −28.5 [−63.3, 6.2]).

Figure 2.

Percent change in global mental health symptoms and mean differences relative to usual care over 9 months: Intent-to-treat, moderate dose, and completers analyses, TRACE Study (n=60). Number of observations at 0, 4, and 9 months: Usual care: 30, 28, 26; CETA-ITT: 30, 27, 25; CETA-Moderate dose: 13, 12, 12; CETA-Completed: 10, 10, 10.

The proportion of participants achieving global symptom response was fairly comparable between arms in the intent-to-treat analysis (4 months: 15% in CETA-PWH vs. 18% in usual care; 9 months: 24% CETA-PWH vs. 27% usual care) but was notably higher in the moderate dose group (33% at 4 and 9 months) and the completers (40% at 4 and 9 months) (Figure 3; SuppTable S2).

Figure 3.

Probability of response (≥50% improvement) and probabilltiy differences relative to usual care over 9 months: Intent-to-treat, moderate dose, and completers analyses, TRACE Study (n=60). Number of observations at 0, 4, and 9 months: Usual care: 30, 28, 26; CETA-ITT: 30, 27, 25; CETA-Moderate dose: 13, 12, 12; CETA-Completed: 10, 10, 10.

Domain-specific mental health outcomes.

Generally, similar patterns were observed when considering each symptom domain separately. For example, among the 40 participants who had an elevated depression score at baseline, in the ITT analysis, the mean percent reduction in PHQ-9 symptoms was greater in the CETA-PWH than the usual care arm at 4 months (MD −16.1 [−45.8, 13.6]) and 9 months (−5.8 [−34.3, 22.7]). Greater benefits were observed in the moderate dose analysis (4 months: −35.5 [−67.5, −3.6]; 9 months: −22.5 [−52.7, 7.7]) and even greater benefits in the completers analysis (4 months: −42.0 [−76.5, −7.4]; 9 months: −29.8 [−62.0, 2.5]) (Supplement; SuppTable S1, S2; SuppFigures S3, S4).

HIV care continuum outcomes.

The HRSA HAB attendance measure was identical between arms in the ITT analysis (73% vs 73%) but showed a slight advantage to the intervention in the moderate dose analysis and the completers analysis (Table 2). Engagement measured by the kept visit proportion was also similar in the ITT analysis (CETA-PWH: 74%; usual care: 70%) but showed a stronger benefit in the moderate dose analysis and the completers analysis. The probability of viral suppression in the ITT analysis was slightly lower in the CETA-PWH arm compared to the usual care arm at 4 months (62% vs. 67%) but slightly higher at 9 months (71% vs. 65%).

Table 2.

Proportion of participants achieving HIV care engagement outcomes by arm: Intent to treat, moderate dose, and completer analyses. Number of observations for each percentage given in parentheses.

					CETA compared to usual care
		CETA			ITT		Moderate dose		Graduators
	Usual care	ITT	Moderate dose	Graduators	PD	95% CI	PD	95% CI	PD	95% CI
HIV care attendance over 12 months
HRSA HAB measure	73.3% (30)	73.3% (30)	76.9% (13)	80.0% (10)	0.0%	(−22.4%, 22.4%)	3.6%	(−24.2%, 31.4%)	6.7%	(−22.7%, 36.1%)
Kept visit proportion	70.3% (30)	74.4% (28)	84.4% (13)	93.0% (10)	4.1%	(−18.9%, 27.1%)	14.1%	(−11.6%, 39.7%)	22.7%	(0.0%, 45.5%)
Viral suppression
4 months	66.7% (27)	61.9% (21)	54.5% (11)	66.7% (9)	−4.8%	(−32.1%, 22.6% )	−12.1%	(−46.5%, 22.3%)	0.0%	(−35.6%, 35.6%)
9 months	65.4% (26)	70.8% (24)	70.0% (10)	66.7% (9)	5.4%	(−20.3%, 31.2%)	4.6%	(−29.2%, 38.4%)	1.3%	(−34.5%, 37.1%)

PD: Proportion difference. CI: Confidence interval. ITT: Intent to treat.

Weighted analyses.

Effect estimates for the moderate dose and completer analyses were substantively unchanged and more precise when corrected for potential confounders (Supplement; SuppFigure S5).

Harms

No deaths, hospitalizations, or other serious adverse events occurred during the study.

Discussion

This pilot randomized controlled trial of CETA-PWH, a transdiagnostic counseling intervention adapted for people with HIV with one or more common mental disorders, demonstrated provocative signals of effectiveness on mental health outcomes and HIV appointment attendance. The intent-to-treat analysis showed substantially greater reduction in global mental health symptoms at 9 months compared to usual care, with benefits increasing as participants received more of the intervention. Although completer analyses of RCTs can be biased by differences between those who do and don’t complete treatment, in our propensity score analysis the effect sizes remained essentially unchanged after correcting for such differences, lending support to the hypothesis that the intervention was the causal factor. This pattern of greater improvement with greater exposure to the intervention generally held when looking at each symptom domain separately.

Although retention in research interviews was high, CETA-PWH session attendance proved challenging. Nearly all intervention participants completed ≥1 CETA-PWH session, but less than half received ≥6 sessions in the first three months and only one-third completed treatment. Completing CETA-PWH required longer treatment and more sessions than has been observed in previous CETA research. Participants in this study took on average 18 sessions to complete CETA-PWH compared to ~7 sessions in prior studies.⁶² Provision of tablets for remote counseling sessions likely improved session attendance for some clients but did not resolve all engagement barriers.

Attendance challenges may be expected given that participants were eligible based on having an indicator of HIV treatment engagement challenges. Additionally, patients at this clinic experience substantial socioeconomic stress (~80% of patients have household income <200% of the federal poverty level) and participants reported high levels of substance use, which can interfere with routine session attendance.⁵¹ However, those who did attend sessions experienced substantial mental health benefit as well as some indication of improved HIV care engagement, suggesting a strong potential benefit if CETA-PWH engagement barriers can be overcome. Notably, participants had much higher completion rates for research outcome visits (85–92%), for which reimbursement was provided, than for the uncompensated CETA-PWH sessions. Strategies that support session attendance and completion, such as motivational interviewing⁶³ or incentives for therapy attendance,⁶⁴ could allow more clients to realize the mental health and HIV care benefits of CETA-PWH.

This pilot trial launched approximately eight months into the COVID-19 pandemic, leading to innovations such as providing tablets for remote counseling and research interview completion. COVID-19 may have affected clinic attendance, although sessions could be held remotely. COVID-19 may also have affected participants’ mental health, although both arms experienced the pandemic.

This pilot study supports other literature^43,65,66 that demonstrates the pronounced need for a transdiagnostic counseling approach in PWH. Although individuals only needed one elevated mental health domain to enroll, two-thirds had at least three elevated domains. Further, the lifetime trauma burden of participants was extremely high. Many other studies have highlighted the high prevalence of trauma history and mental health comorbidity among PWH in the US and particularly the US South. ^43,65,66

The modular approach of CETA-PWH means that patients receive components and dosages of therapy based on both clinical need and patient preference. Despite the prevalence of substance use problems, substance use reduction was identified as a treatment goal for only 25% of patients. This may reflect patient preference to focus on other symptoms over substance use; however, substance use problems could undermine engagement.

Strengths of this pilot RCT include the individually randomized design, high levels of research follow-up, protection against contamination, comprehensive measures of mental health and HIV care continuum outcomes, outcome follow-up through 9 months, and pragmatic inclusion and exclusion criteria. One notable limitation was the large proportion of intervention participants who did not complete CETA-PWH, an important finding of this pilot study that informs subsequent trials. The small sample size, by design, limits firm conclusions about intervention effectiveness from this pilot trial. Oral administration of the research outcome interviews could have introduced social desirability bias into responses, although there is not a clear reason to believe any such bias would differ by arm. We used inverse probability weights to correct for potential confounding in our moderate dose and completer analyses. To avoid overfitting with the limited sample size, we focused on the three variables with the greatest likelihood of introducing confounding. The role of additional factors such as counselor fidelity, mode of delivery, and other clinical characteristics should be explored in a larger trial.

Our sample is reflective of the patient population at the study site and generally in the southeastern US; however, our data do not necessarily reflect patient experiences at other US HIV clinics. On average, study patients received their HIV diagnosis a decade prior to enrollment. HIV-related stigma can be a barrier to HIV treatment engagement particularly for newly diagnosed patients.⁶⁷ Although stigma can be addressed by CETA-PWH, newly diagnosed patients may need tailored engagement strategies to benefit from CETA-PWH.

This pilot trial provides provocative indications of the potential for CETA-PWH, a transdiagnostic counseling intervention, to improve mental health and HIV care engagement among PWH. Although this pilot study was not powered for effectiveness, large mental health benefits were observed among those who completed the full course of treatment, along with improved care engagement. Additional engagement strategies may be necessary to ensure more clients can fully engage in treatment and realize its full benefits.

Data availability statement:

The datasets generated during and/or analyzed during the current study are not publicly available, but are available from the corresponding author on reasonable request.