Battling Stigma for Service Engagement among Women with HIV in Vietnam

Abstract:Women living with HIV/AIDS (WLHA) bear a higher level of stigma because of their socio-cultural vulnerabilities. Women are more likely to internalize social stigma and produce a sense of shame and loss of self-worth, which results in a delay in health service seeking and compromised health outcomes. In Vietnam, stigma towards WLHA is exacerbated by the deeply rooted female inferiority culture. However, research targeting WLHA is generally lacking. We propose this study to address stigma among WLHA and explore the use of virtual support system in WLHA’s service engagement in Vietnam. The 2-year study will proceed in two phases in Hanoi, Vietnam. Phase 1 will be formative studies, including in-depth interviews with 30 WLHA and focus groups with 20 service providers and community stakeholders. This phase aims to investigate the cultural and contextual background of HIV and gender roles in Vietnam and to identify effective strategies to support and engage WLHA in healthcare. These formative findings will inform the development of an intervention to be pilot tested in the next phase. Phase 2 will be a 6-month intervention pilot with 90 WLHA using an online/offline hybrid approach. During Month 1 of the pilot, WLHA will participate in an in-person section to form mutual support groups and prepare for the following online components. During Month 2-4 of the pilot, study investigators will teach WLHA a series of empowerment strategies to cope with stigma and utilize social support to seek healthcare services. These skills will be taught via interactive online group activities. During Month 4-6, WLHA will self-administer the online groups without the intervention of study investigators. WLHA’s multidimensional stigma measures, mental health burdens, and service use self- efficacy will be assessed at baseline, month 4, and month 6. Progress data of the intervention will be documented to inform the feasibility and sustainability of the online support approach. Acceptability data and feedback will be collected from the WLHA participants upon completion of the 6-month pilot period.

Project Number: 1R21TW012018-01

https://reporter.nih.gov/search/9c5dRBJyvkGOpSB3l9HRSw/project-details/10302007

 

Contact PI/ Project Leader

LIN, CHUNQING,  (lincq@ucla.edu)

 

Organization

UNIVERSITY OF CALIFORNIA LOS ANGELES

 

PUBLIC HEALTH RELEVANCE: HIV stigma and discrimination have enormous negative impacts on women, and reducing internalized stigma has significant implications for the effort to engage women in HIV prevention and care. This proposed study will devise strategies to empower women living with HIV in Vietnam to combat HIV and gender intersectional stigma. This study will lead to implementable and scalable approaches to promote women living with HIV’s mental health and service seeking not only in Vietnam but also globally.

 

 

Project Start Date: 17-September-2021

Project End Date: 31-May-2023

Budget Start Date: 17-September-2021

Budget End Date: 31-May-2022

 

NIH Categorical Spending

Funding IC:  NATIONAL INSTITUTE OF DRUG ABUSE + FOGARTY INTERNATIONAL CENTER / FY Total Cost by IC: $219,421

Evaluating STI screening and antimicrobial resistance in Neisseria gonorrhoeae among PrEP users in Vietnam

Abstract: Men who have sex with men (MSM) are at higher risk for HIV and sexually transmitted infections (STIs) that increase HIV risk, such as Neisseria gonorrhoeae and Chlamydia trachomatis. HIV pre-exposure prophylaxis (PrEP) users—many of whom are MSM—are also at increased risk for STIs. U.S. guidelines recommend that PrEP users undergo frequent screening in multiple anatomic sites (pharyngeal, urogenital, and rectal) for asymptomatic infections. However, lower- and middle-income countries (LMICs) lack such guidelines, resulting in missed opportunities for STI screening and treatment among LMIC PrEP users. Antimicrobial resistance (AMR) in N. gonorrhoeae is an urgent global health threat and the prevalence is highest in LMICs, where access to diagnostics is limited. In particular, the Western Pacific Region, which includes the LMIC of Vietnam, has seen increasing spread of AMR in N. gonorrhoeae, which has spread worldwide. Major gaps exist in understanding the drivers of AMR in N. gonorrhoeae in LMICs. In this study, investigators from UCLA and Hanoi Medical University will investigate the acceptability and feasibility of C. trachomatis and N. gonorrhoeae screening among MSM and transwomen engaged in an HIV PrEP program in Hanoi, Vietnam. We hypothesize that screening will be acceptable and feasible. We will also investigate risk factors for AMR and genomic relationships between commensal Neisseria and N. gonorrhoeae at genetic loci associated with AMR, hypothesizing that recent antibiotic use is a risk factor for AMR. AIM 1: (a) To determine the distribution of anorectal, pharyngeal, and urogenital C. trachomatis and N. gonorrhoeae infections among MSM and transgender women PrEP users (n=1,300) in Hanoi, Vietnam and (b) To evaluate the acceptability and feasibility, including willingness to pay, of rapid, triple-site testing. AIM 2: (a) To collect, culture, and perform antibiotic susceptibility testing on N. gonorrhoeae and oropharyngeal Neisseria species to investigate the prevalence and correlates of AMR and b) To perform whole-genome sequencing on pairs of N. gonorrhoeae and Neisseria species isolated from within the same individual to investigate relationships within genes associated with antimicrobial resistance in N. gonorrhoeae. This two-year project has four phases. Phase 1 will last three months and will involve development of study materials, planning, and training. Phase 2 will last one year and will evaluate acceptability and feasibility of C. trachomatis and N. gonorrhoeae screening. Phase 3 will last 9 months and will involve antimicrobial susceptibility testing and whole genome sequencing. Phase 4 will last 3 months and will involve dissemination of findings through manuscripts, presentations, and sharing of data with local government and health agencies. Findings from the study will form the foundation for a future R01-proposal to investigate the impact of routine screening and treatment of STIs on the development of antimicrobial resistance is N. gonorrhoeae.

Project Number: 7R21AI157817-02

https://reporter.nih.gov/search/yKo7fj4CsEeWn001nA2peA/project-details/10389089

 

Contact PI/ Project Leader

KLAUSNER, JEFFREY DAVID, CLINICAL PROFESSOR (jdklausner@med.usc.edu)

 

Organization

UNIVERSITY OF SOUTHERN CALIFORNIA

 

PUBLIC HEALTH RELEVANCE: In the proposed study, we will evaluate the acceptability and feasibility of rapid, triple-anatomic-site screening for Chlamydia trachomatis and Neisseria gonorrhoeae infections within a cohort of men who have sex with men (MSM) and transgender women on HIV pre-exposure prophylaxis (PrEP) in Hanoi, Vietnam. We will determine the distribution of C. trachomatis and N. gonorrhoeae infections by anatomic site, test N. gonorrhoeae and commensal Neisseria species for antimicrobial susceptibility, and perform whole genome sequencing on N. gonorrhoeae and Neisseria species to investigate genetic markers of antimicrobial resistance. Findings from this study will characterize the burden of STIs among PrEP users in Vietnam while also providing insight into the correlates of antimicrobial resistance in N. gonorrhoeae and identifying genetic factors associated of with resistance.

 

 

Project Start Date: 05-February-2021

Project End Date: 31-January-2023

Budget Start Date:  12-May-2021

Budget End Date: 31-January-2022

 

NIH Categorical Spending

Funding IC:  NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES/ FY Total Cost by IC: $220,833

Linking Refugees to HIV Clinical Care in Uganda

Abstract: There are an estimated 3.4 million refugees living in sub-Saharan Africa, a region of the world which hosts 71% of the global population living with HIV. Displaced for an average of 17 years, refugees are a vulnerable population at risk of exposure to HIV due to violence and persecution. With competing survival needs, language and cultural barriers, and disrupted social networks, refugees face unique challenges accessing HIV care. HIV prevalence in refugee settlements in sub-Saharan Africa is often unknown and HIV research in this population is limited. Candidate: During my research fellowship, I conducted a clinic-based routine HIV testing study in Nakivale Refugee Settlement in Uganda demonstrating that only 54% of newly diagnosed HIV-infected clients linked to care. I am applying for a K23 Career Development Award to acquire the skills to become an independent investigator focused on understanding linkage to HIV care for refugees and developing interventions to improve engagement in care for this unique population. Mentoring: Dr. Ingrid Bassett (Mentor) is an expert on linkage to HIV care in resource-limited settings and winner of the Harvard Medical School Young Mentor Award. I will also be guided by Co-Mentors, Dr. Paul Spiegel (the Deputy Director of the Division of Programme Support and Management at the United Nations High Commissioner for Refugees [UNCHR], expert in the structural dimensions of refugee health), Dr. Edgar Mulogo (HIV researcher, faculty in Uganda), and Dr. Laura Bogart (expert in behavioral science, HIV intervention research, and qualitative methods). Committed advisors include Dr. Richard Mollica (Director of the Harvard Program in Refugee Trauma), Dr. Alexander Tsai (psychiatrist, expert on psychosocial intervention research for HIV- infected people in Uganda), Dr. Julius Kasozi (UNHCR in Uganda, expert in refugee health and Uganda health policy), Dr. Michael VanRooyen (Director of the Harvard Humanitarian Initiative), Dr. Norma Ware (qualitative methods), and Dr. Robert Parker (biostatistics, HIV trial design). Research: Within the social-ecological framework, I will 1) use qualitative methods to understand barriers to HIV care and means to overcome barriers for refugees in Nakivale; 2) prospectively enroll a cohort of HIV-infected refugees to assess which social-ecological factors correlate with failure to link to HIV care in Nakivale; and 3) use intervention mapping methodology to develop, implement, and evaluate a pilot intervention to improve linkage to HIV care in Nakivale. Training: The research is supported by training in health behavior theory and ecologic context of HIV care in resource-limited settings with an in-depth focus on mental health, analytic techniques including survey and geographic information system methods, and intervention development. The project will provide training and pilot data needed to develop an R01 application for a randomized HIV linkage intervention trial in three refugee settlements in Uganda. With my dedication to evaluating interventions to improve care for refugees, support from an exceptional mentoring team, strong institutional commitment, and an innovative research plan, I am well-positioned to become an independent clinical investigator focused on refugee health.

Project Number: 5K23MH108440-06

https://reporter.nih.gov/search/qs4MWlGAxUeMKzbgrNfMIA/project-details/9935159

 

Contact PI/ Project Leader

BOGART, LAURA M, SENIOR BEHAVIORAL SCIENTIST (LBOGART@RAND.ORG)

 

Organization

RAND CORPORATION

 

PUBLIC HEALTH RELEVANCE: Refugees in sub-Saharan Africa face considerable hardships accessing HIV clinical care. I propose to evaluate barriers to linkage to HIV care and potential means to overcome those barriers in Nakivale Refugee Settlement in Uganda. I will develop and pilot a refugee-specific linkage intervention to assess whether this strategy improves engagement in care for newly diagnosed HIV-infected clients in the settlement.

 

 

Project Start Date: 01-August-2019

Project End Date: 31-May-2022

Budget Start Date: 01-June-2020

Budget End Date: 31-May-2022

 

NIH Categorical Spending

Funding IC:  NATIONAL INSTITUTE OF MENTAL HEALTH / FY Total Cost by IC: $186,192

Behavioral Economics Incentives to Support HIV Treatment Adherence in Sub-Saharan Africa

Abstract: It is imperative to find ways to improve retention boost ART adherence in sub-Saharan Africa where adherence rates have been found to decline over time, and where treatment options such as second-line regimens are very limited. A promising tool is the Lottery Incentives to Facility Treatment Adherence (LIFT) program suggested in this proposal, i.e. the use of small prizes for healthy HIV-related behavior allocated by a drawing. LIFT is based on the results of the applicant’s R34 `Rewarding Adherence Program (RAP)’ [R34 MH096609] that demonstrated feasibility and acceptability of lottery incentives for HIV-related behaviors, and established preliminary efficacy. The current R01 application will build on these promising results with the aim to a) use viral loads as biological endpoints that were not included in the R34 for cost reasons; b) establish efficacy in a fully powered intervention including comparative efficacy of two different ways of implementing the lottery incentives (incentivization of adherence; incentivization of timely clinic visits and viral suppression) and; c) establish the cost effectiveness of these two implementation modes as a further input for policy-makers. The intervention is targeted at increasing the motivation of treatment-mature clients who have been on ART for several years through the added benefit and joy of potentially winning a prize, thereby attempting to overcome the treatment `fatigue’ that can develop in the context of mundane, daily pill taking over the course of life-long treatment. Insights from behavioral economics suggest that such an intervention may be particularly effective for people with present bias (i.e. those who have a tendency to give in to short-term temptation at the cost of more long-term benefits) that was found to be prevalent among HIV clients in the R34 study. LIFT will be implemented among 330 adult clients who have been on ART for at least two years in three groups: for the first intervention group, timely clinic attendance will determine the number of entries they receive for winning a monthly prize, and participants are eligible for an annual lottery based on viral suppression. The second treatment group will be incentivized on high demonstrated ART adherence, including at an additional annual lottery. The control group will receive the usual standard of care. All participants will receive MEMS caps to record adherence and five study assessments over 24 months (at baseline and every 6 months thereafter). The first Specific Aim will be to evaluate the effectiveness of LIFT; the second aim is to compare the effectiveness of the adherence-based arm and the revised arm directly incentivizing viral suppression that subsequently could be incorporated into clinical care as it does not require costly devices and instead relies only on information available in the clinic. The third Specific Aims is to perform a comparative cost- effectiveness analysis of the two LIFT intervention arms as a further policy input.

Project Number: 5R01MH110350-05

https://reporter.nih.gov/search/3MnscHY5qkaP-H3GhQ-H-A/project-details/10205950

 

Contact PI/ Project Leader

LINNEMAYR, SEBASTIAN, ECONOMIST (slinnema@rand.org)

 

Organization

RAND CORPORATION

 

PUBLIC HEALTH RELEVANCE: For public health it is important to improve adherence to antiretroviral drugs and support viral suppression, especially in resource-constrained countries in which treatment options are limited, and for an increasing number of treatment-mature clients who have been on ART for several years. Our study will investigate the role of small lottery incentives in improving these HIV-related behaviors and health outcomes that can be used in combination with other strategies. The current R01 application builds on the promising results of an earlier R34 study that demonstrated acceptability, feasibility, and preliminary efficacy of such incentives.

 

 

Project Start Date: 13-September-2017

Project End Date: 30-June-2022

Budget Start Date: 01-July-2021

Budget End Date: 30-June-2022

 

NIH Categorical Spending

Funding IC:  NATIONAL INSTITUTE OF MENTAL HEALTH / FY Total Cost by IC: $290,065

Evaluating the PrEP cascade in HIV-negative pregnant and breastfeeding women in South Africa (PrEP-PP)

Abstract: HIV-negative pregnant and breastfeeding women in South Africa are at extremely high risk of HIV acquisition despite increased access to and initiation of antiretroviral therapy (ART) in South Africa. We urgently need effective interventions to reduce HIV incidence in pregnant and breastfeeding women. Currently PrEP is one of the only female controlled methods that is effective for preventing HIV acquisition. PrEP-PP is a study of pre-exposure prophylaxis (PrEP) among HIV-1 seronegative Pregnant and Postpartum women in two South African urban primary health care facilities. Effective use of PrEP could contribute to eliminating maternal HIV acquisition, and hence eliminating mother to child HIV transmission (MTCT). However, PrEP efficacy requires adherence during periods of sexual activity and adherence requires PrEP access, awareness and counseling. Currently, a major obstacle in the field is the lack of knowledge of women’s initiation, retention and adherence to PrEP during pregnancy and breastfeeding periods in Africa. Now is the time to evaluate how best to provide PrEP to vulnerable pregnant and breastfeeding women as WHO recently developed guidelines for providing PrEP in pregnancy and breastfeeding women but there are limited data on acceptability, initiation and adherence in pregnant and breastfeeding women in Africa where the burden of HIV is greatest. Our study will focus on the following specific aims: 1. Determine the distribution of women across the PrEP cascade (initiation, retention, and adherence) and outcomes (HIV acquisition, transmission, and adverse events) in a cohort of pregnant and breastfeeding women in Cape Town, South Africa 2. Evaluate patient and provider-level factors associated with the PrEP cascade (initiation, retention and adherence) using quantitative and qualitative approaches 3. Apply an established mathematical model to simulate the impact of improvement in the PrEP cascade on HIV infections averted (maternal and perinatal) Our PrEP-PP study is urgent and essential to understand the PrEP cascade in pregnant and breastfeeding women in South Africa and to identify factors associated with PrEP initiation and adherence to develop interventions to ensure that everyone in this at-risk population can benefit from PrEP. The results from the PrEP-PP study will provide a model for the South African Government, and other Governments in the region, to scale up PrEP delivery among pregnant and breastfeeding women at risk of HIV acquisition and perinatal transmission and contribute to the elimination of perinatal HIV transmission.

Project Number: 1R01MH116771-01A1

https://reporter.nih.gov/search/dkK25PIoW0KfsaDd4N5FHw/project-details/9623865

 

Contact PI/ Project Leader

COATES, THOMAS J., PROFESSOR IN RESIDENCE (tcoates@mednet.ucla.edu)

 

Organization

UNIVERSITY OF CALIFORNIA LOS ANGELES

 

PUBLIC HEALTH RELEVANCE: HIV-negative pregnant and breastfeeding women in South Africa (SA) are populations at very high risk of HIV acquisition. Pre-exposure prophylaxis (PrEP) is one of the only female controlled methods that can prevent HIV acquisition. Our study, PrEP-PP, will evaluate the PrEP cascade ( PrEP initiation, retention, adherence) and patient and provider-level factors associated with the PrEP cascade to inform future PrEP programs.

 

 

Project Start Date: 15-September-2018

Project End Date: 30-June-2023

Budget Start Date: 15-September-2018

Budget End Date: 30-June-2019

 

NIH Categorical Spending

Funding IC:  NATIONAL INSTITUTE OF MENTAL HEALTH / FY Total Cost by IC: $579,553

Engaging men through HIV self-test and differentiated care models to increase ART initiation and viral suppression in Malawi

Abstract: Men continue to be missed by HIV testing and treatment services. Index partner testing is a critical strategy for reaching men. Index HIV self-testing (HIVST), whereby ART clients take HIVST kits home to their sexual partners for testing, is a new strategy that dramatically increases index testing among men, and is being taken to scale across Malawi. However, only 25% of men identified as HIV-positive through Index HIVST initiate ART after 6- months. Innovative strategies to increase ART initiation and retention among men are urgently needed. The overarching goal of the proposed R01 is to test a home-based ART intervention (ART initiation + 3-months ART care) plus motivational interviewing to increase ART initiation and 6-month viral suppression among men who test HIV-positive through Index HIVST in Malawi. The specific aims are: (1) test the effectiveness of home-based versus facility-based ART on ART initiation and 6-month viral suppression among male partners who test through Index HIVST; (2) Identify predictors of ART initiation and 6-month viral suppression; and (3) Determine the cost and cost-effectiveness of home-based ART versus facility-based among male partners using Index HIVST. The trial will provide urgent information on innovative HIV service delivery strategies for hard-to-reach-populations, such as men. Findings are expected to inform national policy and international recommendations around combined differentiated models that reach across the HIV treatment cascade.

Project Number: 1R01MH122308-01A1

https://reporter.nih.gov/search/C5ftR11Y1USYYpNuXQjMzg/project-details/10013734

 

Contact PI/ Project Leader

COATES, THOMAS J., PROFESSOR IN RESIDENCE (tcoates@mednet.ucla.edu)

 

Organization

UNIVERSITY OF CALIFORNIA LOS ANGELES

 

PUBLIC HEALTH RELEVANCE: Men in sub-Saharan Africa who test HIV-positive continue to have poor ART initiation and retention outcomes. The proposed project will test a home-based ART intervention for men who use HIV self-testing (HIVST) strategies compared to facility-based ART. Findings will provide essential information on how to best reach men across the testing and treatment continuum, a critical step to curbing the HIV epidemic.

 

 

Project Start Date: 17-June-2020

Project End Date: 31-May-2025

Budget Start Date: 17-June-2020

Budget End Date: 31-May-2021

 

NIH Categorical Spending

Funding IC:  NATIONAL INSTITUTE OF MENTAL HEALTH / FY Total Cost by IC: $643,041

Expedited Partner Therapy and the HIV Prevention Cascade Among MSM in Peru

Abstract: Expedited Partner Therapy (EPT) offers a unique tool to combine HIV prevention and STI control through an integrated HIV Prevention Cascade. In providing empiric, patient-delivered antibiotic treatment to the recent sexual partners of individuals with bacterial STIs, EPT promotes partner notification, HIV/STI testing, and treatment, and triggers the critical first step of an HIV prevention cascade culminating in uptake of antiretroviral-based prevention methods (such as PrEP or pre-exposure prophylaxis), and ultimately a reduction in community-level HIV transmission risk. By targeting the sexual partners of individuals with new STI diagnoses, EPT provides an opportunity to identify nodes of active HIV and STI transmission within high-risk sexual networks, to promote HIV testing and linkage to prevention and treatment services among these individuals, and to potentially reducing the incidence of HIV/STI transmission within the larger population. Use of EPT for HIV/STI control among MSM presents three key questions for future research: i) What is the impact of EPT on biological outcomes of persistent or recurrent bacterial STIs among MSM? ii) What is the effect of EPT on prevention cascade outcomes of partner HIV/STI testing and linkage to HIV prevention/treatment services? and iii) Would any observed increases in prevention cascade outcomes lead to community-level reductions in HIV/STI transmission? Aim 1 (Individual). To determine the effect of EPT on individual-level outcomes of partner notification and persistent or recurrent GC/CT infection among MSM. Aim 2 (Partnership). To assess the impact of EPT on partner-level outcomes of notification, testing, STI treatment, and linkage to HIV prevention and treatment services. Aim 3 (Population). To use Agent Based Modeling to estimate the impact of EPT for MSM on HIV/STI transmission at network- and population-levels.

 

Project Number: 1R01MH118973-01A1

https://reporter.nih.gov/search/8uQzJnqO4kGvjo0HMuZ8FQ/project-details/9781083

 

 

Contact PI/ Project Leader

CLARK, JESSE LAWTON, ASSISTANT PROFESSOR-IN-RESIDENCE (jlclark@mednet.ucla.edu)

 

 

Organization

UNIVERSITY OF CALIFORNIA LOS ANGELES

 

 

PUBLIC HEALTH RELEVANCE: Expedited partner therapy (EPT) following STI diagnosis offers a unique strategy to integrate STI control with HIV prevention among men who have sex with men (MSM). Our study uses EPT as a tool to trigger the HIV prevention cascade among at-risk MSM in Lima, Peru.

 

 

Project Start Date: 01-June-2019

Project End Date: 31-March-2024

Budget Start Date:01-June-2019

Budget End Date:31-March-2020

 

 

NIH Categorical Spending

Funding IC:  NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES + NATIONAL INSTITUTE OF MENTAL HEALTH / FY Total Cost by IC: $561,476

Combining Positive Deviance and Implementation Science to Improve Retention in HIV Care in South Africa

Abstract:Despite notable increases in antiretroviral therapy (ART) adherence and decreases in mortality, South Africa is not close to achieving the UNAIDS goals of 90% of all people living with HIV (PLWH) diagnosed, 90% of those with a positive HIV diagnosis on antiretroviral therapy (ART), and 90% of those on ART with undetectable HIV RNA by 2020, with only 60% of all PLWH having undetectable RNA as of 2017. Moreover, in the Western Cape, the viral load suppression (VLS) rate (54.7%) is the second lowest in the country, and the average 6- month rate for retaining PLWH in primary health care clinics is 64%. Retention is critical for improving ART adherence and VLS. Clinics face myriad challenges retaining PLWH in care long enough to maintain VLS. Structural-, organizational-, and individual-level patient barriers impede retention. Nevertheless, a handful (about 8%) of health care clinics consistently have retention rates at 80% or above. Information about how these clinics manage to succeed despite pervasive barriers could help improve retention rates in clinics that are not performing as well. Positive Deviance (PD) is an approach to studying ways in which a minority of individuals or organizations succeed despite barriers that typically hinder success. The approach begins with a “discover” phase in which intensive study is undertaken to uncover unique strategies of clinics with better outcomes than those facing similar challenges, followed by an implementation phase in which the strategies are implemented. In a collaboration among the RAND Corporation, the South African Human Science Research Council, and the South African Western Cape Department of Health, we propose (1) to use a PD approach and mixed methods research (a provider survey that assesses contextual factors thought to be associated with performance; patient shadowing; semi-structured interviews with clinic leaders, and focus groups with providers and patients) to discover strategies used by primary health care clinics that retain 80% or more of PLWH in care; (2) to develop an intervention that consists of a toolkit with novel PD strategies identified in Phase 1 and implementation science methods for successfully implementing strategies; and (3) to implement the PD intervention in 3 low-performing pilot clinics and conduct a pilot cluster randomized trial to evaluate (a) feasibility (extent to which the PD strategies are implemented); (b) acceptability (clinic staff attitudes about the toolkit, the strategies, and implementation processes); and (c) preliminary effects of the intervention on PLWH retention in care and VLS. To determine feasibility, we will collect attendance logs and activity worksheets; to assess acceptability, we will conduct focus groups with providers and patients; to assess preliminary effectiveness, we will examine changes in patient retention and VLS at intervention clinics from 6-months before the intervention and during the intervention period, compared to changes in all other low- performing clinics. The proposed study would be the first to experimentally test a PD intervention to improve retention in HIV care for PLWH; if effective, it could lead to higher retention and VLS rates and lower mortality.

 

Project Number: 5R34MH119889-03

https://reporter.nih.gov/search/NOajWrXy_UCgpi4QmSgvzQ/project-details/10304143

 

 

Contact PI/ Project Leader

OBER, ALLISON, ASSOCIATE BEHAVIORAL SCIENTIST (ober@rand.org)

SKINNER, DONALD HARRY 

 

 

Organization

RAND CORPORATION

 

 

PUBLIC HEALTH RELEVANCE: Retaining people living with HIV in care in primary health care clinics in the Western Cape (WC) of South Africa, a region with high HIV prevalence and the second lowest viral load suppression (VLS) rates in the country, is an ongoing challenge. Retention is associated with greater antiretroviral therapy adherence and VLS, but clinics in the WC only retain an average of 64% of patients who begin treatment. The proposed study will combine a Positive Deviance approach with implementation science methods to identify clinics in the WC with retention rates above 80% (currently 8% of all clinics have achieved this), employ quantitative and intensive qualitative methods to discover unique strategies that might be contributing to high retention rates, and develop and implement in the lowest performing clinics a novel, clinic-level intervention to test feasibility, acceptability and preliminary effects on retention and VLS; if effective, the intervention ultimately could lead to greater retention and VLS and lower mortality in the region and elsewhere.

 

 

Project Start Date: 01-December-2019

Project End Date: 30-November-2022

Budget Start Date: 01-December-2021

Budget End Date: 30-November-2022

 

 

NIH Categorical Spending

Funding IC: NATIONAL INSTITUTE OF MENTAL HEALTH/ FY Total Cost by IC: $250,689

Controlled Trial of Game Changers: A Group Intervention to Train HIV Clients to be Change Agents for HIV Prevention in Uganda

Abstract:In Uganda, HIV prevalence is estimated to be 6.2% among those aged 15-64, and is higher (6.9%) in Kampala, the proposed study setting. Political and cultural barriers, including limited government funding and HIV stigma, impede HIV prevention and have led to projections of rapid increases in HIV incidence. The proposed research will be a randomized controlled trial (RCT) of Game Changers, a 6-session peer-led group intervention that aims to empower and mobilize people living with HIV (PLWH) to be agents for HIV prevention in their social networks. By decreasing stigma among PLWH and their social network members, and training PLWH on strategies to engage social network members in discussions around HIV, Game Changers provides PLWH with the tools to do prevention advocacy. Game Changers was developed through an NIMH R34 that found high feasibility and acceptability, and preliminary intervention effects on increased HIV prevention advocacy between PLWH and their social network members, reduced internalized stigma, and increased HIV-serostatus disclosure to social network members among PLWH, and medium to large effects on increased condom use and HIV testing among a subsample of network members. The Specific Aims are: (1) To conduct an RCT of Game Changers, a peer- led group intervention for PLWH in Uganda, to test intervention effects on the primary outcomes of reduced condomless sex, increased HIV testing, and decreased enacted HIV stigma among social network members; (2) To test intervention effects on the secondary outcomes of reduced internalized HIV stigma, increased HIV serostatus disclosure, and increased viral load suppression among PLWH, and PrEP uptake among social network members; (3) To examine whether increased HIV prevention advocacy by PLWH mediates intervention effects on social network members’ increased condom use and HIV testing, and whether increased HIV disclosure by PLWH mediates intervention effects on social network members’ reduced enacted HIV stigma; and (4) To conduct a cost-effectiveness analysis of the intervention. We will recruit 210 PLWH, randomizing 105 to the intervention and 105 to an attention control. Each PLWH will be asked to recruit social network members to complete assessments (736 total, 368/arm), to test intervention effects on social networks. All participants will complete surveys at baseline and 6-, 12-, and 18-months post-baseline; PLWH will also complete social network assessments. The cost-effectiveness analysis will inform policymakers about whether Game Changers is a feasible intervention in which to invest. Our approach is particularly timely in the era of biomedical interventions, which require widespread penetration of effective HIV prevention messaging into communities. Positioning PLWH as central to the solution for controlling (vs. causing) the HIV epidemic has the potential to reduce HIV stigma and improve prevention outcomes at the individual, household, and network levels.

 

Project Number: 1R01MH126691-01A1

https://reporter.nih.gov/search/d28T3sYPEkSxvEsRxFXQ6Q/project-details/10319366

 

 

Contact PI/ Project Leader

BOGART, LAURA M, SENIOR BEHAVIORAL SCIENTIST (LBOGART@RAND.ORG)

WAGNER, GLENN JOHN, BEHAVIORAL RESEARCH SCIENTIST (GWAGNER@RAND.ORG)

 

 

Organization

RAND CORPORATION

 

 

PUBLIC HEALTH RELEVANCE: The proposed study aims to conduct a randomized controlled trial to empower people living with HIV to be critical agents of behavior change within their social networks in Uganda, where virtually every family is touched by someone living with HIV. Positioning people living with HIV as central to the solution for controlling (vs. causing) the HIV epidemic has the potential to reduce HIV stigma and improve HIV prevention behaviors at the individual, household, and network levels.

 

 

Project Start Date: 06-July-2021

Project End Date: 31-May-2026

Budget Start Date:06-July-2021

Budget End Date: 31-May-2022

 

 

NIH Categorical Spending

Funding IC: NATIONAL INSTITUTE OF MENTAL HEALTH / FY Total Cost by IC: $804,979

Screen, Treat and Retain Meth-Using People with Opioid Use Disorders at MMT Clinics (STAR-OM)

Abstract: We propose to develop and evaluate optimal combinations of evidence-based interventions (EBIs) to improve HIV outcomes and reduce methamphetamine use among people with opioid use disorder (OUD) who are in methadone maintenance therapy (MMT) in Vietnam (STAR-OM study). Over the past decade, the expansion of MMT has contributed to stemming both HIV and opioid epidemics. However, rising methamphetamine use threatens these achievements. The twinned epidemics of opioid and methamphetamine use have also been reported in the US and other countries. Building on our pilot work with MMT patients in Hanoi, through collaborative work with local MMT providers and patients, we will refine adapted EBIs to develop an adaptive design that offers an individualized approach to treatment. The adaptive design includes: (1) Two frontline interventions: 6 weeks of CM then 6 weeks of weekly group educational sessions (low intensity CM) and 12 weeks of CM (high intensity CM); (2) One (short-term) tailoring outcome: urine tests negative with meth metabolites in both week 11 and 12 are considered responsive to frontline interventions; (3) Three alternative interventions: those with positive outcomes will move to 12-week maintenance stage and receive two daily SMS reminders plus one weekly self-monitoring assessment message. Non-responders will move to 12-week enhanced treatment stage and are randomized to either Matrix group counseling only or Matrix group counseling plus CM. We will compare effectiveness of two frontline interventions and four adaptive interventions with a Sequential Multiple Assignment Randomization Trial in 200 HIV+ (150 from HCMC; 50 from Hanoi) and 400 HIV- (200 from each city) MMT patients who report moderate- and high-risk meth use on self-screening with tablet-based ASSIST and/or have urine positive with methamphetamine metabolites. In each location, the study will stratify participants by HIV status before randomizing them to one of two frontline interventions. Primary outcomes – including HIV viral suppression, HIV risk behaviors, and meth use (reported and urine tests) – will be assessed at 12, 24 and 48 weeks. We will calculate the incremental cost effectiveness ratio (ICER) comparing cost-effectiveness between two frontline interventions as well as among four adaptive strategies. Finally yet importantly, we also conduct ethnographic observations and in-depth interviews with MMT clinic managers, clinical staff and MMT patients (N=60, 30 per city) to identify structural, provider and patient-level factors that influence adoption and scale-up of the adaptive interventions. Findings from this study with Type I Hybrid design to evaluate EFFECTIVENESS-Implementation will provide valuable evidence to develop treatments in resourced and resourced-constrained settings to confront the twinned epidemics of opioid and methamphetamine use in the context of surging HIV epidemic due to drug abuse.

 

Project Number: 5R01DA050486-02

https://reporter.nih.gov/search/riWejVstsU64q25DeFfslA/project-details/10171837

 

 

Contact PI/ Project Leader

SHOPTAW, STEVEN J, DIRCETOR (SShoptaw@mednet.ucla.edu)

 

Organization

HANOI MEDICAL UNIVERSITY

 

 

PUBLIC HEALTH RELEVANCE: The twinned epidemics of opioid and methamphetamine use have been reported in the US and other countries such as Vietnam. We propose to develop and evaluate optimal combinations of evidence-based interventions to improve HIV outcomes and reduce methamphetamine use among people with opioid use disorders who are in methadone maintenance therapy. Lessons learned from this study may inform the development of responses in the US as well as other resourced and resourced-constrained settings.

 

 

Project Start Date:01-June-2020

Project End Date: 31-March-2025

Budget Start Date: 01-April-2021

Budget End Date: 31-March-2022

 

 

NIH Categorical Spending

Funding IC: NATIONAL INSTITUTE ON DRUG ABUSE/ FY Total Cost by IC: $473,025

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