Using Novel Approaches to Evaluate Behavioral Interventions: Overlooked Significant HIV Prevention Effects in the HPTN 015 Project EXPLORE

Pitpitan, Eileen V.; MacKinnon, David P.; Eaton, Lisa A.; Smith, Laramie R.; Wagman, Jennifer A.; Patterson, Thomas L.

doi:10.1097/qai.0000000000002711

Cited by 4 publications

(4 citation statements)

References 31 publications

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“…40,41) and related approaches such as identifying mediators of intervention effects (eg, Ref. 42), on the whole, interventions are typically evaluated solely between arms with little consideration of differential results among subgroups. The main consequence of this latter approach is that it does not capture how subgroups respond to the intervention and the resultant effects of the intervention.…”

Section: Discussionmentioning

confidence: 99%

Novel Latent Profile Analysis of a Test of Concept, Stigma Intervention to Increase PrEP Uptake Among Black Sexual Minority Men

Eaton

Layland

Driver

et al. 2023

JAIDS Journal of Acquired Immune Deficiency Syndromes

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Background: Pre-exposure prophylaxis (PrEP) has demonstrated efficacy for HIV prevention, yet uptake of PrEP among populations in urgent need of prevention tools (eg, Black sexual minority men) is limited, and stigma and medical mistrust remain strong barriers to accessing PrEP. Purpose: To evaluate a test of concept brief intervention to address stigma and medical mistrust as barriers to PrEP uptake using novel latent profile analysis. Methods: Participants (N = 177) residing in the southeastern US were randomized to 1 of 4 arms to establish the potential impact of a brief, stigma focused counseling intervention (referred to as Jumpstart) to increase PrEP uptake. We estimated intervention effect size (Cramer's V) for PrEP uptake and then explored differential intervention effects across latent profiles of psychosocial barriers to PrEP use. Results: The intervention resulted in small, but meaningful effect size, with self-reported PrEP uptake increasing across Jumpstart conditions with the control condition reporting 24% uptake and Jumpstart plus text/phone calls (the most intensive intervention arm) reporting 37% uptake, and a similar pattern emerging for biologically confirmed PrEP use. Among participants 30 and older, Jumpstart participants were more likely to move to a postintervention profile with fewer barriers than control participants and reported the highest uptake of PrEP. Conclusions: Addressing social/emotional barriers to PrEP uptake is an essential component of bridging the gap between advances being made in biomedical forms of HIV prevention, and establishing and supporting access to those advances.

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Section: Discussionmentioning

confidence: 99%

Novel Latent Profile Analysis of a Test of Concept, Stigma Intervention to Increase PrEP Uptake Among Black Sexual Minority Men

Eaton

Layland

Driver

et al. 2023

JAIDS Journal of Acquired Immune Deficiency Syndromes

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“…Mediation and/or moderation analyses were infrequently conducted in the identified studies, potentially masking additional findings that may prove statistically, clinically, or behaviorally significant. Prior research has demonstrated the value of revisiting trial data to examine mediators and moderators of findings, including non-significant findings [ 66 ]. Primary outcome analysis is often restricted to main effects averaged over all participants, and reanalyzing data from those trials (whether originally efficacious or not) by including mediators and/or moderators in analytic models may reveal scientifically and practically important findings.…”

Section: Discussionmentioning

confidence: 99%

“…Primary outcome analysis is often restricted to main effects averaged over all participants, and reanalyzing data from those trials (whether originally efficacious or not) by including mediators and/or moderators in analytic models may reveal scientifically and practically important findings. For example, mediation and moderation analysis of trial data may yield significant findings that were initially undetected in the primary outcome analysis, including new intervention-to-outcome mechanistic pathways, or previously unidentified subgroups for whom the intervention demonstrated greater or lesser efficacy [ 66 ]. Notably, several studies in this review reported significant intervention effects on non-HIV care continuum outcomes (e.g., reduced substance use, condomless sex, gender-based violence, increased social support).…”

Section: Discussionmentioning

confidence: 99%

Promoting HIV care continuum outcomes among people who use drugs and alcohol: a systematic review of randomized trials evaluating behavioral HIV care interventions published from 2011 to 2023

Pitpitan,

Wiginton,

Bejarano-Romero

et al. 2023

BMC Public Health

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Background Substance use remains a robust predictor of HIV infection and a serious impediment to HIV care continuum progression for people living with HIV. The primary research question of this systematic review is focused on understanding the extent to which behavioral HIV care interventions have been efficacious in helping people who live with HIV and who use substances along the HIV care continuum. Methods Using PubMed and ProQuest databases, we performed a systematic review of randomized trials of behavioral HIV care continuum interventions among people who use substances published from 2011 to August 2023, since the beginning of the treatment-as-prevention era. Results We identified 11 studies (total participants: N = 5635), ten intentionally targeting substance-using populations. Four studies involved samples using ≥ 1 substance (e.g., alcohol, opioids, stimulants, marijuana); four involved injection drug use; one involved methamphetamine use; and one involved alcohol use. One study targeted a population with incidental substance use (i.e., alcohol, injection drug use, non-injection drug use reported in most participants). Each study defined one or more HIV care outcomes of interest. Viral suppression was an outcome targeted in 9/11 studies, followed by uptake of antiretroviral therapy (ART; 7/11), ART adherence (6/11), retention in care (5/11), and linkage to care (3/11). While most (nine) of the studies found significant effects on at least one HIV care outcome, findings were mostly mixed. Mediated (2/11) and moderated (2/11) effects were minimally examined. Conclusions The results from this systematic review demonstrate mixed findings concerning the efficacy of previous HIV care interventions to improve HIV care continuum outcomes among people who use substances. However, heterogeneity of study components (e.g., diversity of substances used/assessed, self-report vs. objective measures, attrition) prevent broad deductions or conclusions about the amenability of specific substance-using populations to HIV care intervention. More coordinated, comprehensive, and targeted efforts are needed to promote and disentangle intervention effects on HIV care continuum outcomes among substance-using populations.

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“…Mediation and/or moderation analyses were infrequently conducted in the identified studies, potentially masking additional findings that may prove to be statistically, clinically, or behaviorally significant. Revisiting trials whose outcome analyses were restricted to main effects averaged over all participants and reanalyzing data from those trials (whether originally efficacious or not) by including mediators and/or moderators in analytic models may reveal significant findings undetected initially, including new intervention to outcome pathways or previously unidentified subgroups for whom the intervention demonstrated greater or lesser efficacy (Pitpitan et al, 2021). Notably, several of the studies in this review did report significant intervention effects on non-HIV care continuum outcomes (e.g., reduced substance use, condomless sex, gender-based violence; increased social support).…”

Section: Discussionmentioning

confidence: 99%

Promoting HIV care continuum outcomes among people who use drugs and alcohol: A systematic review of randomized trials published from 2011 to 2021

Pitpitan

Wiginton

Romero

et al. 2022

Preprint

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Substance use remains a robust predictor of HIV infection, as well as a serious impediment to progress across the HIV care continuum for people living with HIV. As such, the careful design and implementation of interventions uniquely tailored to target substance use and HIV care behaviors remain paramount. A necessary step in these efforts is to understand the extent to which HIV care interventions have been efficacious in helping people who use substances progress across the HIV care continuum. Using PubMed and ProQuest databases, we performed a systematic review of randomized trials of HIV care continuum interventions among people who use substances published between 2011 and 2021, the treatment-as-prevention era. Existing systematic reviews and studies in which less than half of those sampled reported substance use were excluded. We identified ten studies (total N=5410; range: 210-1308), nine of which intentionally targeted substance-using populations. Four of these studies involved use of at least one of several substances, including alcohol, opioids, stimulants, and/or marijuana, among others; three involved injection drug use only; one involved methamphetamine use only; and one involved alcohol use only. One study targeted a population with incidental substance use, which involved use of alcohol, injection drug use, and non-injection drug use. Viral suppression was targeted in 8/10 studies, followed by uptake/initiation of antiretroviral therapy (ART; 6/10), ART adherence (6/10), retention to care (4/10), and linkage to care (3/10). For each outcome, intervention effects were found in roughly half of the studies in which a given outcome was assessed. Mediated (2/10) and moderated (2/10) effects were minimally examined. The diversity of substances used in and across studies, as well as other characteristics that varied across studies, prevented broad deductions or conclusions about the amenability of specific substances to intervention. Moreover, study quality was mixed due to varying attrition and assessment measures (self-report vs biological/clinical). More coordinated, comprehensive, and targeted efforts are needed to disentangle intervention effects on HIV care continuum outcomes among populations using diverse substances.

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Using Novel Approaches to Evaluate Behavioral Interventions: Overlooked Significant HIV Prevention Effects in the HPTN 015 Project EXPLORE

Abstract: Supplemental Digital Content is Available in the Text.

Cited by 4 publications

References 31 publications

Novel Latent Profile Analysis of a Test of Concept, Stigma Intervention to Increase PrEP Uptake Among Black Sexual Minority Men

Novel Latent Profile Analysis of a Test of Concept, Stigma Intervention to Increase PrEP Uptake Among Black Sexual Minority Men

Promoting HIV care continuum outcomes among people who use drugs and alcohol: a systematic review of randomized trials evaluating behavioral HIV care interventions published from 2011 to 2023

Promoting HIV care continuum outcomes among people who use drugs and alcohol: A systematic review of randomized trials published from 2011 to 2021

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