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

SMS as an Incentive to Adhere (SITA)

Abstract: HIV care requires high medication adherence to achieve optimal clinical outcomes such as slowing the progression to AIDS. Youths face special and unique challenges to adherence. Despite a wealth of interventions designed to increase adherence outcomes, few have focused on interventions that are sustainable in resource-limited settings, or for the period of adolescence. Developing ways to increase adherence rates among adolescents is particularly important as this groups experiences the fastest growth in new HIV/AIDS cases. Existing interventions often require scarce human resources, limiting their practical use. Novel ways of adapting traditional interventions in a sustainable manner are important in resource-limited settings, where second-line therapy is often too expensive or altogether unavailable. The recent rapid rise in mobile phone coverage and ownership among developing country populations has spawned the advent of mobile-phone based interventions to improve health service delivery; short message service (SMS)-based interventions have been found to increase adherence rates to ART among adult patients. However, more knowledge about this promising technology is needed as currently no clear-cut evidence exists about the pathways through which they work. The proposed study ‘SMS as an Incentive To Adhere’ (SITA) proposes novel ways of using SMS messages that are explicitly grounded in the theoretical framework of Social Cognitive Theory (SCT). The first intervention is that of self-monitoring, i.e. providing participants with feedback about their adherence performance. Traditionally this involves clinic visits that take up provider and patient time and resources; SIT instead suggests providing objective, real-time information measured by electronic monitoring (Wisepill) devices sent to patients by weekly SMS. Such feedback builds self-efficacy, a key SCT concept and so may contribute to improved adherence. The second intervention is based on the SCT concept of social learning. Perceived group norms, and interventions that affect those perceptions, are a key influence on health behavior among youths, providing a substitute for direct learning. This approach is adapted to a mHealth environment by providing patients not only with their own adherence information but also that of a reference (peer) group. The first aim of the study is to hold focus groups with key stakeholders to tailor the SMS-intervention to the local needs of youths. The second aim planned is a small, six-month randomized controlled trial testing the two SITA intervention groups against a control condition of usual care to determine which method of informing and motivating drug adherence can best achieve its goals. The third aim is to synthesize lessons learned and discuss them with the clinics and other key stakeholders. The purpose of such capacity building and knowledge transfer activities part of this study is to build up mHealth knowledge at Mildmay and Uganda more generally to a point where ideas can be generated and implemented locally.

Project Number: 5RMH107218-02

Implementation Science for Intervention Delivery in Healthcare Settings

Abstract:  Implementation science examines the efficiency of intervention implementation and to translate the existing efficacious intervention models to real world services. It could potentially enhance the effectiveness and sustainability of the behavioral intervention projects. I received my PhD in epidemiology from the University of California, Los Angeles (UCLA) in 2009. Through my involvement in several large-scale HIV behavioral intervention projects and my doctoral dissertation study, I realized the importance of implementation science in intervention delivery and determined long-term career goal to become an implementation science researcher to bridge the gap between existing knowledge and service delivery. To fill in the gap between my current skill set and the career goal, I will receive training in areas related to implementation science, including health policy, intervention adaptation, and healthcare management. The health policy training will familiarize me with the process of policy development and its influence on the intervention adaptation and implementation; the intervention adaptation courses will inform me with the general concept and framework to design the study ensuring all aspects of intervention implementation are addressed; and the health management training will provide me with analytical tools to model leadership decision making and to evaluate the implementation flow in healthcare settings. The mentor team members, Drs. Li Li, Mary-Jane Rotheram-Borus, Thomas J. Coates and Zunyou Wu, are all internationally reorganized experts in behavioral intervention implementation and adaptation. My institute, the UCLA Semel Center for Community Health (CCH) and the Center for HIV Identification, Prevention, and Treatment Services (CHIPTS), UCLA, provide me with support from a multidisciplinary team of top researchers. Collaborating with the National Center for AIDS/STD Control and Prevention (NCAIDS), China CDC, I will conduct a mentored research using an intervention trial with significant yet heterogeneous outcome to investigate multilevel factors influencing the intervention implementation and outcome, and to find the optimal approach to incorporate the intervention model into the current healthcare settings. The study will be conducted in three phases. Phase 1 will be review of related policies and in-depth interviews with healthcare administrators and hospital directors, with the aim to explore the policy barriers and facilitators in adaptation of the intervention model. Phase 2 will be conjoint analysis with hospital directors to model the decision-making in intervention adaptation and routinization in the healthcare facilities. Phase 3 will be bottleneck analysis to locate structure bottlenecks in compliance with the intervention component. The finding will provide implications for future intervention delivery in healthcare settings. Application of some analytical tools in other fields, including conjoint analysis and bottleneck analysis, will potentially contribute to the development of implementation science methodology. Based on the data achieved from the study, I will prepare for a R01 application in implementation science in Year 4 of the K award period.

Project Number: 5K01MH1021447-05

Enhancing the Role of Commune health Workers in HIV and Drug control in Vietnam

Abstract: This 5-year project aims to enhance the role of commune health workers (CHWs) in HIV and drug use prevention and treatment. We demonstrate the process of development, implementation, and evaluation of an integrated intervention for CHWs, IDUs, and their family members (FMs) in Vietnam. In Phase 1, intervention topics, format, delivery procedures, and supporting materials are developed through a series of focus group discussions. In Phase 2, implementation pilot and process evaluation are conducted to collect feedback from participating CHWs, IDUs, and their FMs by in-depth interviews in two commune health centers. In Phase 3, we conduct an intervention trial (CHW CARE intervention) in 60 commune health centers (5 CHWs, 15 IDUs and 10 FMs from each commune center), totaling 300 CHWs; 900 IDUs and 600 FMs. Randomization occurs at the commune level (30 communes assigned to the intervention group; 30 communes assigned to the control group). At each commune assigned to the intervention, the intervention is delivered to CHWs first, and the participating CHWs are required to conduct individual and group sessions with IDUs and FMs in their communes. The efficacy of the intervention is assessed at baseline, 3, 6, 9, and 12-month follow-ups by comparing outcome measures of CHWs, IDUs and FMs in the intervention group to those in the control group. Relationships between the intervention outcomes of CHWs, IDUs, and FMs are explored.

Project number: 4R01DA03360-05

MMT CARE for HIV Prevention: A Randomized Controlled Trial

Abstract: This project uses a combination prevention approach to respond to the urgent need for improved quality of services at methadone maintenance therapy clinics, provider-client interactions, and client outcomes.

We conduct the 5-year randomized controlled trial that targets methadone maintenance treatment (MMT) programs in China. Applying the principles of combination prevention, the intervention (MMT CARE) integrates psychosocial and behavioral components into a pharmacological framework for methadone maintenance. A total of 68 MMT clinics are randomly selected from five provinces. From each clinic, 6 service providers and 36 clients are recruited, totaling 408 providers and 2,448 clients in the study. The 68 clinics are randomized to 1) an MMT CARE intervention group or 2) a control group (34 clinics each). Service providers who complete the training conduct three individual motivational enhancement sessions with clients. Efficacy of the intervention is evaluated at baseline and at 6, 12, 18, and 24-month follow-ups.

Project Number: 4r01da033160-05

Multimodal Interventions to Improve Adherence to Oral Tenofovir/Emtricitabine as Pre-Exposure Prophylaxis in Women in Southern California

Abstract: Daily oral pre-exposure prophylaxis (PrEP) with tenofovir/emtricitabine (TDF/FTC) as part of a combination prevention package has been shown to be effective for HIV prevention in randomized control trials of MSM and heterosexual men and women at risk for HIV infection; however, some studies in African women have shown lack of efficacy that is believed to be in large part due to inadequate PrEP adherence. In addition, pharmacokinetic studies in women suggest that near-perfect adherence for TDF/FTC oral dosing may be more critical for protection against vaginal compared to rectal exposures. Taken together, these results imply that women may require substantially greater levels of adherence to oral TDF/FTC to effectively decrease HIV acquisition. Therefore, interventions to optimize adherence are particularly vital to maximizing the protective efficacy of PrEP for women. Although current FDA approval and CDC clinical guidelines for oral TDF/FTC as PrEP include at-risk women as candidates for use, limited clinical data exists on the use of PrEP in US women. Further research is needed to advance effective implementation, particularly taking into account the known challenges to achieving and maintaining high levels of adherence for women. In this demonstration project, we will evaluate adherence to, and acceptability of once-daily oral TDF/FTC as PrEP among HIV-uninfected women in Southern California who are at increased risk of HIV acquisition. Los Angeles and San Diego represent two of the top three counties in California of number of reported HIV/AIDS cases. In combination, they total over half of the number of HIV cases in the state supporting the need for ongoing prevention efforts in all at-risk populations (1). Working in tandem, the LAC PATH and CCTG partnership provides a unique opportunity to further collaborative research that has been fostered within the CHRP funding structure, capitalizing on the strengths of existing individual projects in MSM and transgender women.

An mHealth Platform for Health Care Workers to Link South Africans to HIV Care

Abstract:  The South African National Development Plan recognizes the value of health care delivery models such as home based counselling and testing (HBCT) by aiming to train between 700,000 and 1.3 million community health workers (CHW) to implement community-based health care by 2030. The CHW role include working with households to facilitate access and linkage to primary health care facilities, provide outreach and community organization support, health education and coaching on health system navigation. Key barriers to sustainability and scale-up of community health worker programs include: i) a lack of integration between CHW and the health system; ii) poor tracking of how many people receive health services in their home; and iii) once referrals are successful, inadequate communication about the referral to and from the referral site. The South African health information system is currently ill equipped to handle these challenges and needs to be strengthened. We propose a 2-year study to develop and test a mHealth platform aimed at addressing these challenges for persons living with HIV (PLH). We focus on HIV due to the high prevalence rates in South Africa and impact that mobile technologies can make on HIV care. A mHealth platform will be developed that can be used by CHW to enroll household members and track their movement into and between health facilities. It will provide a standard interface by which current and future systems can query the stored data, thereby increasing interoperability and long term sustainability. The platform will unobtrusively support communication between clinic-based health providers and CHW supervisors. In summary, we aim to:1) Assess the perceived barriers and benefits to implementing an mHealth platform to link PLH to care through key informant interviews and foucs groups with health officials, clinic staff, CHW, and PLH; 2) Develop an mHealth platform that is inexpensive, scalable, open to integration, and can monitor patients from HBCT into facility based health care; and 3) Pilot test the mHealth platform and compare linkage to care between PLH from two communities that deploy our mHealth platform (mHealth communities) and PLH from two control communities where HBCT is currently being conducted without our mHealth platform. In the mHealth communities, we will also evaluate process measures to identify bottle necks between HBCT and visitation to an mHealth clinic.

Project Number5R21MH16351-02

STI Screening as a Combined HIV Prevention Platform for MSM in Peru

Abstract: Periodic counseling, testing, and treatment for rectal sexually transmitted infections (STIs) provides a multi- dimensional platform to integrate behavioral and biological HIV prevention strategies for men who have sex with men (MSM) in Peru. Rectal STIs like gonorrhea and chlamydia are key risk factors for HIV acquisition among MSM, both as indirect behavioral markers of recent unprotected receptive anal intercourse (URAI), and as inflammatory factors that increase cellular risk for HIV co-transmission. However, there have been no prospective studies of interventions addressing the specific behavioral and biological risk factors associated with rectal STI transmission or the potential impact on HIV transmission risk of integrating rectal GC/CT screening with other prevention services. We will use nucleic acid testing to screen 750 behaviorally high-risk MSM for rectal gonorrheal and/or chlamydial (GC/CT) infection. GC/CT-positive subjects will receive single-dose antibiotic treatment and either single-session Personal Cognitive Counseling (PCC) (n=50) or standard post-test counseling (n=50). A GC/CT-negative control group (n=50) will also be enrolled to compare biological outcomes including changes in levels of inflammatory cytokines following rectal STI. Aim 1: To adapt a Personalized Cognitive Counseling (PCC) model for use with MSM in Peru. Aim 2: To adapt and pre-test the SJEI and behavioral assessment instruments for use with MSM in Peru. Aim 3: To pilot a combined HIV prevention intervention based on rectal STI counseling, testing, and treatment for MSM in Peru. Estimates of feasibility/acceptability of the intervention, GC/CT prevalence/re-infection rate and the effect on behavioral and biological mediators of HIV infection will be used to plan an R01 evaluation of rectal STI surveillance as HIV prevention for MSM in Peru.

Project Number: 5R01MH105272-03

Pilot Intervention to Empower HIV Clients as Prevention Advocates in Uganda

Abstract:  People living with HIV/AIDS (PLHA) have a critical role to play in HIV prevention, not only in the context of Prevention for Positives and Treatment as Prevention, but as powerful change agents for HIV protective behaviors among others. Our research suggests that as PLHA receive HIV treatment and restore their health and functioning, many are motivated to protect their loved ones and engage in prevention advocacy (i.e., to encourage friends and family to seek HIV testing and treatment, and to reduce risk behavior); however, the quality of this advocacy is hampered by challenges related to message content, style and timing of delivery, and selection of advocacy recipients. With effective advocacy training, mobilizing PLHA to be change agents within their social networks has the potential to be a “game changer” for HIV prevention, particularly in high prevalence settings such as Uganda, where virtually every family is touched by someone living with HIV. Drawing upon theoretical frameworks for network-based interventions, such as theories of social diffusion, cognitive consistency, and social influence, the proposed study will develop and pilot test “Game Changers”– an intervention that aims to empower and mobilize PLHA to be agents for HIV prevention and behavioral change in their social networks. In Phase 1, we will conduct separate focus groups of PLHA and members of their social networks (family and friends) to explore barriers to and facilitators of mobilizing clients to advocate for HIV prevention, perceptions on how advocacy can be most effective in motivating behavior change, and how to best structure the intervention and its content. In Phase 2 we will use findings from Phase 1, and draw from network-based intervention models to develop the structure and content of an intervention designed to help clients cope with stigma, manage their disease, live positively, and develop motivation and skills for HIV disclosure and prevention advocacy. In Phase 3 we will pilot the group intervention in a controlled trial of 96 clients, with 48 randomly assigned to receive the intervention and 48 to the wait-list control. Assessments will be administered to all participants at baseline and months 4, 8 and 12, after which the control group will receive the intervention. Surveys and social network assessments will examine intervention effects on protective behaviors of the participant (condom use, HIV treatment adherence), and diffusion of prevention messages across the network, as assessed by the content and extent of communication with network members about protective behaviors (condom use, partner concurrency/number of partners, HIV testing, engagement in HIV care, circumcision), HIV disclosure, and HIV stigma. Game Changers is innovative as it encompasses aspects of all major HIV prevention paradigms, targets advocacy to all network members rather than within and by specific risk groups, and uses social network data not only to evaluate effects but also strategically target advocacy. Findings will inform a larger R01 trial.

Project Number: 5R36MH111460-02

Mobile Phone Adherence and Prevention Support for People Living with HIV in India

The 2.3 million persons living with HIV (PLH) in India are being offered access to anti-retroviral therapies (ARV) by the government. ARVs offer the possibility of improving the individual’s health and to reduce transmission by decreasing viral load. Yet, non-adherence remains high, typically around 50% (WHO, 2008). Mobile phones have been used in the US and globally to increase ARV adherence among PLH. As a low cost, easily diffused intervention strategy in a country such as India in which the mobile phone penetration rate is expected to reach 74% by 2013 and 101% by 2014 (Informa World, 2010), designing a mobile phone intervention to increase ARV adherence is a potentially highly efficacious intervention. In this proposal, we aim to adapt an existing mobile phone system for ARV adherence for PLH in India. However, because HIV is a chronic infectious disease, PLH are also challenged with maintaining mental health and reducing transmission risks (Swendeman et al., 2009a). Furthermore, reviews and meta-analyses have concluded that ARV adherence interventions are more effective when a comprehensive approach is adopted (Malta, 2008; Rueda, 2006; Simoni, 2006). In particular, mental health symptoms and transmission acts that co-occur with and undermine ARV adherence (Kalichman, 2008, Malta, 2008) are likely to be behaviors that may also be influenced by mobile phone delivered intervention.

This R21 aims to adapt and develop two versions of a mobile phone program to enhance medical adherence: 1) one aimed solely at increasing medication and appointment adherence; and 2) one aimed at increasing adherence, plus reducing mental health symptoms and transmission acts.

Three world-renowned HIV prevention and technology organizations will collaborate: 1) UCLA CHIPTS, with expertise in behavioral intervention development, adaptation, and randomized trials for PLH and other high risk populations; 2) Durbar, with expertise in multi-level prevention and support services for high risk populations in India; and 3) Dimagi Inc., a technology company with expertise in mobile phone solutions for global health challenges. Dimagi has developed “ARemind” to assess and remind ARV and appointment adherence with feedback from PLH and providers in the U.S. and tested in a pilot study and subsequent SBIR funded study. The software assesses and reminds PLH through text messaging (i.e. Simple Messaging Service [SMS]) or Interactive Voice Response (IVR) methods. This program can also be leveraged to address the co-morbid challenges of preventing transmission and improving mental health and quality of life for PLH. In this study, ARemind will be adapted and developed for PLH in Kolkata, India to address the co-morbid challenges of ARV adherence, transmission risk reduction, and poor mental health faced by PLH. ARemind will be adapted and developed for PLH recruited from two sites in Kolkata, India; 1) a community based care and treatment center operated by Durbar serving primarily female sex workers living with HIV (i.e., the Mamata Care & Treatment Center [MCTC]), and 2) PLH recruited from the primary ARV center in Kolkata operated by the Government of India.

In Phase 1 over Year 1, focus groups with PLH (n=10 from each site) and design meetings with the UCLA and Durbar research team and Dimagi programmers will identify acceptable and feasible enhancements to iteratively adapt and pilot test ARemind for PLH in India. In addition, the team will further develop the program into “ARemind Plus” to also address the co-occurring challenges of mental health and transmission risks for PLH. Dimagi will program adaptations, which will be iteratively pilot tested by research teams in Kolkata overseen by Durbar and trained by UCLA, with small groups of PLH (n=10 from each site).

In Phase 2, over Year 2, we will preliminarily evaluate the efficacy of the enhanced system with 400 PLH (n=200 from each site), with PLH randomized within site to ARemind Plus (n=100 each site) compared to ARemind for medication adherence only as standard care control (n=100 each site). PLH will be recruited with informed consent and complete a baseline and 3 follow-up interviews at 2-month intervals over 8 months to assess the impacts of ARemind compared to baseline adherence rates, and the impacts of ARemind Plus compared to ARemind for adherence only. ARemind for medical adherence will be the standard care control because ARemind and other electronic adherence reminders (e.g., beepers, pagers, timers) have already been established as improving ARV adherence. PLH will be provided with low cost mobile phones that cost about the same as one months supply of ARV medication in India (<$25), which could be a cost- effective strategy for eventual scale up. Both the choice of the standard care and mobile phone provision are warranted by values of distributive justice and ethical conduct of research. Finally, from months 22-24, we will collect post-intervention feedback from PLH and providers, conduct data analyses, and prepare ARemind for dissemination and subsequent field trials and adaptations in India.

Specific Aims:

Our aims are to:

1. Adapt the ARemind program for PLH in Kolkata, India;

2. Further develop ARemind to address factors the co-occurring factors of ARV non-adherence, poor mental health, and transmission risks;

3. Examine the acceptability, engagement, and adherence by PLH to the ARemind programs; and

4. Examine the efficacy of ARemind Plus compared to ARemind for medical adherence only to improve adherence and mental health, and reduce transmission risks, in a pilot randomized controlled trial.

Mobile Phone Adherence and Prevention Support for People Living with HIV in India - Research Plan