A Hybrid Pragmatic and Factorial Cluster Randomized Controlled Trial for an Anti-racist, Multilevel Intervention to Improve Mental Health Equity in High Schools.

Systemic racism is pervasive in US society and disproportionately limits opportunities for education, work, and health for historically marginalized and minoritized racial and ethnic groups, making it an urgent issue of social justice. Because systemic racism is a social determinant of health prevalent across multiple social and institutional structures, it requires multilevel intervention approaches using effective designs and analytic methods to measure and evaluate outcomes. Racism is a fundamental cause of poor health outcomes, including mental health outcomes; thus, mental health services and programs that address racism and discrimination are key to promoting positive mental health of racial and ethnic minority youth. While multilevel interventions are well-suited for improving outcomes like youth mental health disparities, their evaluation poses unique methodological challenges, requiring specialized design and analytic approaches. There has been limited methodological guidance provided to researchers on how to test multilevel interventions using approaches that balance methodological rigor, practicality, and acceptability across stakeholder groups, especially within communities most affected by systemic racism. This paper addresses this gap by providing an example of how to rigorously evaluate a hypothetical, theoretically based, multilevel intervention promoting mental health equity in three US school systems using an anti-racist approach intervening at the macro- (i.e., school system), meso- (i.e., school), and micro- (i.e., family and student) levels to improve mental health in adolescents. We describe the design, sample size considerations, and analytic methods to comprehensively evaluate its effectiveness while exploring the extent to which the components interact synergistically to improve outcomes. The methodological approach proposed can be adapted to other multilevel interventions that include strategies addressing macro-, meso-, and micro-levels of influence.

Interventions to Improve Adolescent HIV Care Outcomes.

PURPOSE OF REVIEW: This review of recent studies evaluating interventions to improve HIV care outcomes among adolescents with HIV (AHIV) was conducted to provide a comprehensive overview of the recent evidence, highlight promising approaches, and suggest directions for future research. RECENT FINDINGS: Our scoping review revealed 65 studies evaluating a variety of interventions and using a range of study designs at various stages of research. Effective approaches included community-based, integrated service delivery models with case management, trained community adolescent treatment supporters, and consideration of social determinants of health. Recent evidence also supports the feasibility, acceptability, and preliminary efficacy of other innovative approaches, including mental health interventions as well as technology-delivered approaches; however, more research is needed to build the evidence base for these interventions. Our review's findings suggest that interventions providing comprehensive, individualized support are essential to improving HIV care outcomes among adolescents. More research is needed to build the evidence base for such interventions and ensure effective, equitable implementation to support the global target of ending the AIDS epidemic by 2030.

Reaching Out-of-school Adolescent Girls and Young Women at Risk for HIV Through Their Social Networks.

Out-of-school adolescent girls/young women (AGYW) in Africa are at increased risk for HIV and are underserved by HIV prevention interventions. Identifying social networks of out-of-school AGYW may be a strategic approach for reaching them. A sequential mixed methods study design was used. The PLACE (Priorities for Local AIDS Control Efforts) methodology, implemented in one ward of Dar es Salaam, Tanzania, identified 69 networks of AGYW. We randomly selected 28 networks and conducted surveys and network assessments with 80.9% (n = 310) of the members. On average, the networks consisted of 13.7 members, and had a density of 0.65 and a transitivity of 0.80, indicating high cohesion. The networks were mostly female (92%). On average, 67% of network membership were AGYW aged 15-24 years, of whom 70% were out-of-school and 67% were sexually active. Among sexually active AGYW aged 15-24, self-reported HIV seropositivity was 12.2%. We then conducted focus group discussions with 6 purposively selected networks. AGYW described their networks as sources of support and advice. Social norms supported AGYW engaging in transactional sex to alleviate life's hardships; it was the easiest way to earn income without "sweating". AGYW discussed IPV as a common experience, and social norms stigmatized AGYWs' use of condoms. AGYW were largely unaware of pre-exposure prophylaxis. The self-reported HIV prevalence rates of this cohort were higher than national averages, suggesting we tapped into high-risk networks. Social norms promoted transactional and unprotected sex. Social networks are an acceptable channel for HIV prevention intervention delivery to out-of-school AGYW.

The Intersection of Intimate Partner Violence Perpetration and Sexual Risk Behavior Among Young Men in Tanzania: A Latent Class Analysis of Patterns and Outcomes.

Few studies of intimate partner violence (IPV) perpetration and sexual risk behavior among men have examined how multiple dimensions of these behaviors intersect in ways that may uniquely elevate health risks. The current study used latent class analysis to: (1) identify distinct patterns of IPV and sexual risk behavior in a sample of Tanzanian men (n = 985) and (2) examine associations between identified patterns and health outcomes. Four classes were identified: normative (64% of the sample), IPV only (14%), sexual risk only (13%), and comorbid IPV/sexual risk (5%). Compared to men in the normative subgroup, men in the comorbid group had significantly higher odds of STI infection, higher perceived HIV risk, and greater odds of substance use. Findings provide evidence that engaging in IPV and multiple sexual partnerships (i.e., a comorbid pattern) denotes elevated health risks across a range of indicators, suggesting the importance of targeted treatment and prevention efforts for men in this subgroup.

RESUMEN: Pocos estudios sobre la violencia infligida por la pareja (IPV) y las conductas sexuales de riesgo entre los hombres han examinado como las múltiples dimensiones de estas conductas pueden combinarse para elevar los riesgos de estas conductas para la salud. El estudio actual utilizó el análisis de clases latentes para: (1) identificar patrones (o clases) distintos de IPV y conductas sexuales de riesgo en una muestra de hombres de Tanzania (n = 985) y (2) examinar asociaciones entre los patrones identificados y indicadores de salud. Se identificaron cuatro clases: normativa (64% de la muestra), IPV solo (14%), riesgo sexual solo (13%) y riesgo sexual / IPV comórbido (5%). En comparación con los hombres del subgrupo normativo, los hombres del grupo comórbido tenían probabilidades significativamente más altas de infección de transmisión sexual, mayor riesgo percibido de VIH, y mayores probabilidades de consumo de sustancias (alcohol y marijuana). Los hallazgos proporcionan evidencia de que ser perpetrador de violencia en pareja y tener múltiples parejas sexuales (un patrón comórbido) es asociado con múltiples riesgos para la salud, lo que sugiere la importancia del tratamiento dirigido y los esfuerzos de prevención para los hombres en este subgrupo.

Predictors of Willingness to Diffuse PrEP Information within Ego-Centric Networks of Women Who Inject Drugs.

Little is known about how social networks among women who inject drugs (WWID) can be leveraged to increase awareness about pre-exposure prophylaxis (PrEP). We tested the hypothesis that interpersonal characteristics influence willingness of WWID to communicate PrEP information with peers. Forty WWID ≥ 18 years completed social network surveys. Participants named on average 9.3 (SD = 3.3) network members, resulting in 375 unique relationships. WWID were willing to share PrEP information with 83% of network members. Participants had higher odds of willingness to share information within relationships when the network member was female, homeless and perceived to be at risk for HIV. Among relationships with family members and transactional sex clients, stronger emotional closeness was associated with higher odds of willingness to share information. Peer interventions where WWID share PrEP information with peers may be an efficient approach to increase PrEP awareness among this vulnerable population.

Women's perspectives on ImpACT: a coping intervention to address sexual trauma and improve HIV care engagement in Cape Town, South Africa.

HIV-infected women who have experienced sexual violence face unique challenges in their HIV care engagement and adherence to antiretroviral medications (ARVs). Improving AIDS Care after Trauma (ImpACT) is a brief counseling intervention aimed at reducing the negative impact of sexual trauma and HIV, building coping skills, and improving long-term HIV care engagement. We conducted a randomized controlled pilot trial of ImpACT with 64 women initiating ARVs in Cape Town, South Africa, with results suggesting the intervention can reduce PTSD symptoms and increase motivation to adhere to ARVs. For the current study, we abstracted data from ImpACT worksheets completed by 31 participants during intervention sessions, and qualitative responses from post-intervention surveys, to examine mechanisms, facilitators, and barriers to change in the intervention. Data included participant descriptions of the values informing their care, barriers to participation, and perceived benefits of the intervention related to coping with trauma and improving care engagement. During the first session, women reported feelings of shame, sadness, and anger that led to social isolation, mistrust, and damaged relationships. Barriers to participation included work and school demands, issues with transportation, finances, and discomfort in talking about HIV and trauma, particularly in group sessions. Despite these challenges, several women stated they developed more positive thinking, felt more confident, and improved their interpersonal relationships. Participants also reported substantial positive impact on symptoms of sexual trauma and motivation to continue with long-term HIV care, and clearer understanding of barriers and facilitators to ARV adherence. ImpACT is a promising intervention model for building adaptive coping skills and adherence to HIV treatment, informed by personal values, among women with a history of trauma in this high-risk setting. The data also offer insights into strategies to strengthen the intervention, overcome barriers to participation, encourage the practical application of skills, and promote long-term HIV care engagement.

eHealth to Enhance Treatment Adherence Among Youth Living with HIV.

PURPOSE OF REVIEW: Multiple reviews have examined eHealth/mHealth interventions to address treatment adherence, including those focusing on youth living with HIV (YLWH). This review synthesizes results of prior reviews and recent studies (last 5 years) to provide a path forward for future research, acknowledging both lessons learned and gaps to be addressed. RECENT FINDINGS: Recent studies provide further evidence for the feasibility and acceptability of technology-based HIV interventions. Formative research of more comprehensive smartphone applications and pilot studies of computer-delivered interventions provide additional guidance on YLWH's preferences for intervention components and show promising preliminary efficacy for impacting treatment adherence. Expanding access to technology among YLWH, in the United States (US) and globally, supports the continued focus on eHealth/mHealth interventions as a means to reduce disparities in clinical outcomes. Future research should lend greater focus to implementation and scale-up of interventions through the use of adaptive treatment strategies that include costing analyses, measuring and maximizing engagement, fostering information sharing between researchers, and building upon sustainable platforms.

Structural Network Position and Performance of Health Leaders Within an HIV Prevention Trial.

The effectiveness of peer leaders in promoting health may depend on the position they occupy within their social networks. Using sociocentric (whole network) and behavioral data from the intervention arm of a cluster-randomized HIV prevention trial in Dar es Salaam, Tanzania, we used generalized linear models with standardized predictors to examine the association between heath leaders' baseline structural network position (i.e., in-degree and betweenness centrality) and their 12-month self-reported (1) confidence in educating network members about HIV and gender-based violence (GBV) and (2) number of past-week conversations about HIV and GBV. As in-degree centrality increased, leaders reported fewer HIV-related conversations. As betweenness centrality increased, leaders reported greater number of conversations about GBV. Network position was not significantly associated with confidence in discussing either topic. Our results suggest that peer leaders who occupy spaces between sub-groups of network members may be more effective in engaging their peers in sensitive or controversial topics like GBV than more popular peer leaders.

Improving AIDS Care After Trauma (ImpACT): Pilot Outcomes of a Coping intervention Among HIV-Infected Women with Sexual Trauma in South Africa.

Improving AIDS Care after Trauma (ImpACT), a coping intervention for HIV-infected women with sexual abuse histories, was evaluated for feasibility and potential efficacy in a public clinic in Cape Town, South Africa. Sixty-four participants were enrolled prior to starting antiretroviral therapy (ART). After completing baseline assessments, participants were randomly assigned to standard of care (SoC: three adherence counseling sessions) or ImpACT (SoC plus four individual and three group sessions). Participants completed assessments at 3 months (after individual sessions) and 6 months post-baseline. In exploratory analysis of primary outcomes, ImpACT participants, compared to SoC, reported greater reductions in avoidance and arousal symptoms of PTSD and greater increases in ART adherence motivation at 3 months. Clinically significant decreases in overall PTSD symptoms were also demonstrated at 3 months. These effects continued as trends at the 6-month assessment, in addition to increases in social/spiritual coping. In analysis of secondary outcomes, high levels of non-adherence to ART and poor care engagement were evident at 6 months, with no differences between study arms. A trauma-focused, culturally-adapted individual intervention delivered by a non-specialist in the HIV care setting is feasible and acceptable. Preliminary findings suggest ImpACT has potential to reduce PTSD symptoms and increase ART adherence motivation, but a more intensive intervention may be needed to improve and maintain care engagement among this population. TRIAL REGISTRATION: ClinicalTrials.gov NCT02223390.

Peer network influence on intimate partner violence perpetration among urban Tanzanian men.

Male perpetration of intimate partner violence (IPV) against women in Tanzania is widespread. Theory and empirical evidence suggest peer networks may play an important role in shaping IPV perpetration, although research on this topic in sub-Saharan Africa is limited. Grounded in social learning theory, social influence theory, and the theory of gender and power, the purpose of this study was to examine whether and how peer networks influence men's perpetration of IPV in Dar es Salaam, Tanzania. We conducted in-depth interviews (n = 40) with a sub-sample of 20 men enrolled in the control condition of an ongoing cluster-randomised controlled trial. We purposively sampled participants who previously reported perpetrating physical IPV. To analyse the data, we generated narrative summaries and conducted thematic and interpretative coding. We saw no evidence that men self-selected into peer networks with certain values or behaviours. Rather, men described several mechanisms through which their peers influenced the perpetration of IPV, including: (1) the internalisation of peer network norms, (2) pressure to conform to peer network norms and (3) the direct involvement of peers in shaping couple power dynamics. Our findings suggest that peer networks influence men's perpetration of IPV and should be targeted in future programmes and interventions.

Associations Between Peer Network Gender Norms and the Perpetration of Intimate Partner Violence Among Urban Tanzanian Men: a Multilevel Analysis.

Male perpetration of intimate partner violence (IPV) against women in sub-Saharan Africa is widespread. Theory and empirical evidence suggest peer networks may play an important role in shaping IPV perpetration, though research on this topic in the region is limited. We assessed the degree to which peer network gender norms are associated with Tanzanian men's perpetration of IPV and examined whether the social cohesion of peer networks moderates this relationship. Using baseline data from sexually active men (n = 1103) nested within 59 peer networks enrolled in an on-going cluster-randomized HIV and IPV prevention trial, we fit multilevel logistic regression models to examine peer network-level factors associated with past-year physical IPV perpetration. Peer network gender norms were significantly associated with men's risk of perpetrating IPV, even after adjusting for their own attitudes toward gender roles (OR = 1.53 , p = . 04). Peer network social cohesion moderated this relationship (OR = 1.50 , p = . 04); the positive relationship between increasingly inequitable (i.e., traditional) peer network gender norms and men's risk of perpetrating IPV became stronger, as peer network social cohesion increased. Characteristics of the peer network context are associated with men's IPV perpetration and should be targeted in future interventions. While many IPV prevention interventions focus on changing individual attitudes, our findings support a unique approach, focused on transforming the peer context.

Social Network Influence on HIV Testing Among Urban Men in Tanzania.

Men in sub-Saharan Africa have low HIV testing rates. Social networks exert an important influence on men's HIV-related behavior. We examined associations between network factors and HIV testing among men in Dar es Salaam, Tanzania. Data are from the baseline assessment of an HIV prevention trial with 48 primarily male networks. Among 923 sexually active men, 52 % had ever tested for HIV. In a random effects logistic regression model, men in the network core were 1.50 times more likely (p < .05) to test than those in the periphery. Percentage of women in the network was associated with men's increased HIV testing (AOR 4.24, p < .05). Perception of network HIV stigma was negatively associated with HIV testing (AOR 0.92, p < .01). Thinking at least one close friend tested for HIV was associated with increased testing (AOR 2.66, p < .001). Social network interventions are a promising approach for scaling up men's HIV testing.

Comparing Perceptions with Actual Reports of Close Friend's HIV Testing Behavior Among Urban Tanzanian Men.

Men have lower rates of HIV testing and higher rates of AIDS-related mortality compared to women in sub-Saharan Africa. To assess whether there is an opportunity to increase men's uptake of testing by correcting misperceptions about testing norms, we compare men's perceptions of their closest friend's HIV testing behaviors with the friend's actual testing self-report using a unique dataset of men sampled within their social networks (n = 59) in Dar es Salaam, Tanzania. We examine the accuracy and bias of perceptions among men who have tested for HIV (n = 391) and compare them to the perceptions among men who never tested (n = 432). We found that testers and non-testers did not differ in the accuracy of their perceptions, though non-testers were strongly biased towards assuming that their closest friends had not tested. Our results lend support to social norms approaches designed to correct the biased misperceptions of non-testers to promote men's HIV testing.

Vijana Vijiweni II: a cluster-randomized trial to evaluate the efficacy of a microfinance and peer health leadership intervention for HIV and intimate partner violence prevention among social networks of young men in Dar es Salaam.

BACKGROUND: Intimate partner violence (IPV) and sexually transmitted infections (STIs), including HIV, remain important public health problems with devastating health effects for men and women in sub-Saharan Africa. There have been calls to engage men in prevention efforts, however, we lack effective approaches to reach and engage them. Social network approaches have demonstrated effective and sustained outcomes on changing risk behaviors in the U.S. Our team has identified and engaged naturally occurring social networks comprised mostly of young men in Dar es Salaam in an intervention designed to jointly reduce STI incidence and the perpetration of IPV. These stable networks are locally referred to as "camps." In a pilot study we demonstrated the feasibility and acceptability of a combined microfinance and peer health leadership intervention within these camp-based peer networks. METHODS DESIGN: We are implementing a cluster-randomized trial to evaluate the efficacy of an intervention combining microfinance with health leadership training in 60 camps in Dar es Salaam, Tanzania. Half of the camps have been randomized to the intervention arm, and half to a control arm. The camps in the intervention arm will receive a combined microfinance and health leadership intervention for a period of two years. The camps in the control arm will receive a delayed intervention. We have enrolled 1,258 men across the 60 study camps. Behavioral surveys will be conducted at baseline, 12-months post intervention launch and 30-month post intervention launch and biological samples will be drawn to test for Neisseria gonorrhea (NG), Chlamydia trachomatis (CT), and Trichomonas vaginalis (TV) at baseline and 30-months. The primary endpoints for assessing intervention impact are IPV perpetration and STI incidence. DISCUSSION: This is the first cluster-randomized trial targeting social networks of men in sub-Saharan Africa that jointly addresses HIV and IPV perpetration and has both biological and behavioral endpoints. Effective approaches to engage men in HIV and IPV prevention are needed in low resource, high prevalence settings like Tanzania. If we determine that this approach is effective, we will examine how to adapt and scale up this approach to other urban, sub-Saharan African settings. TRIAL REGISTRATION: Clinical Trials.gov: NCT01865383 . Registration date: May 24, 2013.

The role of relationship types on condom use among urban men with concurrent partners in Ghana and Tanzania.

Multiple concurrent partnerships are hypothesized to be important drivers of HIV transmission. Despite the demonstrated importance of relationship type (i.e., wife, girlfriend, casual partner, sex worker) on condom use, research on concurrency has not examined how different combinations of relationship types might affect condom use. We address this gap, using survey data from a sample of men from Ghana (GH: n = 807) and Tanzania (TZ: n = 800) who have at least three sexual partners in the past three months. We found that approximately two-thirds of men's reported relationships were classified as a girlfriend. Men were more likely to use a condom with a girlfriend if their other partner was a wife compared to if their other partner was a sex worker (GH: OR 3.10, 95% CI, 1.40, 6.86; TZ: OR 2.34, 95% CI 1.35, 4.06). These findings underscore the importance of considering relationship type when designing HIV prevention strategies in these settings.

A Scoping Review of Approaches to Reduce Stigma and Discrimination Against People with HIV in Health-Care Settings in the United States: Few Recent Interventions Identified.

This scoping review identified contemporary stigma-reduction studies across US health-care settings. Despite the significance of this problem, only 3 intervention studies were identified in the past 5 years. These studies highlight the value of intervening during formative training experiences and the importance of including interprofessional health-care providers in interventions. The findings relate to the novel approaches (eg, virtual patient simulations) that are used in interventions. The importance of using a participatory approach to intervention design is noted. Critical gaps in human immunodeficiency virus (HIV) stigma measurement and the lack of interventions are identified, laying a foundation for future programs and research.

Supporting Adolescents With HIV in South Africa Through an Adherence-Supporting App: Mixed Methods Beta-Testing Study.

BACKGROUND: Novel smartphone app-delivered interventions have the potential to improve HIV treatment adherence among adolescents with HIV, although such interventions are limited. Our team has developed Masakhane Siphucule Impilo Yethu (MASI; Xhosa for "Let's empower each other and improve our health"), a smartphone app-delivered intervention to improve treatment adherence among adolescents with HIV in South Africa. MASI was adapted to the South African cultural context using the HealthMpowerment platform, an evidence-based digital health intervention developed for and with youth in the United States. OBJECTIVE: We conducted this beta-testing study to (1) explore the initial usability of MASI, (2) examine engagement and experiences using MASI features, and (3) inform refinements to the app and intervention implementation plan prior to a subsequent pilot randomized controlled trial (RCT). METHODS: This study was conducted from August 2021 to December 2021 in Cape Town, South Africa. Beta-testing participants received access to MASI for 3 weeks. A mixed methods approach was used, with brief questionnaires and semistructured in-depth interviews conducted prior to app installation and after 1 week to 2 weeks of app testing. Engagement with MASI was measured through analysis of back-end app paradata, and follow-up in-depth interview guides were tailored to each participant based on their app use. RESULTS: Participants in the beta-testing study (6 male participants, 6 female participants; ages 16-19 years) collectively spent 4.3 hours in MASI, averaging 21.4 minutes per participant over the 3-week period (range 1-51.8 minutes). Participants logged into MASI an average of 24.1 (range 10-75) times during the study period. The mean System Usability Scale score was 69.5 (SD 18), which is considered slightly above average for digital health apps. Thematic analysis of qualitative results revealed generally positive experiences across MASI features, although opportunities to refine the app and intervention delivery were identified. CONCLUSIONS: Initial usability of MASI was high, and participants described having a generally positive experience across MASI features. Systematically analyzing paradata and using the interview findings to explore participant experiences allowed us to gain richer insights into patterns of participant engagement, enabling our team to further enhance MASI. The results from this study led to a few technological refinements to improve the user experience. Enhancements were also made to the intervention implementation plan in preparation for a pilot RCT. Lessons learned from the conduct of this beta-testing study may inform the development, implementation, and evaluation of similar app-delivered interventions in the future.

Development and implementation of a process evaluation for intervention quality improvement of a community-based behavioral HIV intervention trial in Tanzania.

Aim: Process evaluations for social and behavioral interventions are increasingly important as interventions become more complex and multi-faceted. Conducting process evaluations in low-resource international settings can be challenging. Process evaluations in low-resource international settings can help inform and improve quality of ongoing intervention implementation. We conducted a process evaluation of a cluster-randomized controlled trial to assess the efficacy of a microfinance and health leadership program on sexually transmitted infections and intimate partner violence perpetration among young men in Tanzania. Subject and Methods: Our trial included 1,491 participants and the intervention lasted two years. We collected process data on microfinance loan uptake and repayment, and health leaders' health conversations with peers to monitor intervention reach and dose received. We developed a database system that allowed offline data collection and synced to a central database when internet was accessible. Research staff in the U.S. accessed data from the central database to analyze and create regular implementation reports. Results: Process graphical reports facilitated identification of implementation challenges and enabled us to resolve issues before they worsened. For example, from a group with low microfinance loan repayment we learned area participants perceived the loan to be a grant, and then we clarified the misinformation with participants. Conclusions: The process evaluation helped inform ongoing intervention implementation, including approaches to improve reach and uptake of interventions. Field staff time was protected by systemizing the sharing of data processing and analyses across the global team.

MASI, a Smartphone App to Improve Treatment Adherence Among South African Adolescents and Young Adults With HIV: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: Adolescents and young adults with HIV repeatedly demonstrate low rates of antiretroviral therapy (ART) adherence as well as low rates of viral suppression. Digital health interventions are a promising way to engage adolescents and young adults with HIV to support ART adherence. However, few digital health interventions have been developed and tested with adolescents and young adults in countries like South Africa, where the HIV burden among adolescents and young adults is greatest. Masakhane Siphucule Impilo Yethu (MASI; Xhosa for "Let's empower each other and improve our health") is a comprehensive ART adherence-supporting app for South African adolescents and young adults with HIV. It was culturally adapted using the HealthMpowerment platform. OBJECTIVE: The aim of this paper is to describe the protocol for a pilot randomized controlled trial examining the feasibility, acceptability, and preliminary efficacy of MASI on self-reported ART adherence and social support. METHODS: We will enroll 50 adolescents and young adults with HIV ages 15-21 years. Participants will be recruited from public ART clinics linked to a large government-funded teaching hospital in Cape Town, South Africa. Participants will be randomized 1:1 into either the intervention arm receiving a full version of MASI or the control arm receiving an information-only version of the app (n=25 per arm). Participants will be asked to engage with MASI daily for 6 months. All participants will complete baseline and follow-up assessments at 3 and 6 months. RESULTS: Study screening began in May 2022 and the first participant was enrolled on June 21, 2022. As of June 12, 2023, 81 participants have completed screeners, and 36 eligible participants have been enrolled in the pilot randomized controlled trial. Recruitment is anticipated to last through August 31, 2023, with study activities anticipated through February 29, 2024. CONCLUSIONS: There is an urgent need for innovative interventions to improve ART adherence among adolescents and young adults in settings like South Africa. If found to be feasible and acceptable, MASI could be implemented with adolescents and young adults with HIV in other parts of the country. TRIAL REGISTRATION: ClinicalTrials.gov NCT04661878; https://clinicaltrials.gov/ct2/show/study/NCT04661878. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47137.