Posts classified under: Adults

HPTN-077

Abstract: To evaluate the safety, tolerability, pharmacokinetics and acceptability of the injectable agent, GSK1265744 long-acting injectable (744LA), in healthy, HIV-uninfected men and women. It is a multi-site, double-blind, two-arm, randomized, placebo-controlled trial of the safety, tolerability, and acceptability of 744LA. HPTN-077 will study HIV-uninfected men and women at low to minimal risk for acquiring HIV infection, ages 18 to 65. of approximately 176 men and women, randomized 3:1, with 132 in the active drug arm, and 44 in the placebo arm. It is anticipated that approximately 60% of the enrolled participants will be women. Participants will be randomized to receive daily oral GSK1265744 (30 mg tablets) or daily oral placebo for 4 weeks, followed by a one-week washout, to assess safety and tolerability before they receive injections. After safety and tolerability assessments from the oral phase have been completed (if no concerns are identified), participants will enter the injection phase of the study and will receive two intra-muscular (IM) gluteal injections of 744LA (800 mg, administered as two 400 mg injections) or placebo (matching vehicle control) at three study visits performed at 12-week intervals.

Project Number: 5UM1AI068619-11

Resiliency Education to Reduce Depression Disparities

Abstract: Depression is the leading cause of adult disability and common among lesbian, gay, bisexual (LGB) adults. Primary care depression quality improvement (QI) programs can improve outcomes for minorities more significantly than for nonminorities, but they are seldom available in safety-net systems. We build on findings from Community Partners in Care (CPIC) and Building Resiliency and Increasing Community Hope (B-RICH). CPIC compared depression QI approaches across healthcare and social /community services in communities of color. CPIC included healthcare and “community-trusted” programs (e.g., homeless, faithbased) to work as a network to address depression, compared to individual-program technical assistance. In CPIC, both conditions improved mental wellness, mental health quality of life, and depression over 12 months. B-RICH, a randomized study, evaluated lay delivery of a seven-session, CBTinformed resiliency education class versus case management on patients’ depressive symptoms over three months, in unpublished but completed analyses. The proposed demonstration supplements the resiliency class with a mobile/interactive voice response case management tool to reinforce class content and depression care reminders (BRICH+).

 

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

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

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 Number: 5R21MH16351-02

Structural Pathways for South African Men to Reduce Substance Abuse and HIV

Young men aged 18-25 years in South Africa face the intersecting epidemics of HIV, alcohol and drug abuse, and unemployment. This R34 is designed to reduce young men’s risk by addressing three problems with existing evidence-based programs (EBP): interventions are not designed considering men’s fight-flight coping strategy; donors are unwilling to invest in substance abusing men; and existing job training does not consider young men’s poor habits. Our goal is to apply behavioral economists’ strategies to new delivery formats that are highly attractive to young men: soccer and job training. A neighborhood-level HIV prevention strategy will shape men’s positive daily routines at an organized soccer league: being on time, completing practice, arriving sober & drug free, showing sportsmanship, and being nonviolent. Employment training by artisan trainers/mentors will be contingently offered to young men who demonstrate positive habits-of-daily-living on 80% of days over two months. Young township men in two neighborhoods will be randomized to receive the intervention that includes soccer, job training, and contingency management to shape behaviors (N=1 neighborhood; n=60 males) or to receive the control condition of soccer and job training without contingency management (n=1 neighborhood; 60 males).

Assessments will be at baseline and 6 months follow-up. We hypothesize the program will significantly reduce HIV-related sexual risk acts and substance abuse, and sustain more employment. We will evaluate life goals, consistency of daily routines pro-social acts, & family relationships. We will primarily evaluate intervention feasibility and uptake, and preliminarily evaluate intervention impacts and mediating factors for reducing HIV risk acts & substance use. We will also document stakeholders’ perceptions of the program’s challenges and successes via Key informant interviews, the number of young men in shebeens over time via observations, and the key features of the social movement strategies of the Sonke Gender Justice, a men’s advocacy movement.

HIV prevention efforts for young people in Sub-Saharan Africa have largely been unsuccessful: novel, structural, community level programs that address the social determinants of HIV are needed (Fenton, 2010; NIAID, 2010; Gupta et al., 2008). In particular, young South African men face many barriers, relative to women, to access and utilize HIV prevention programs, including that:

  • Young men are more likely to have concurrent sexual partners, abuse multiple substances, drop-outof school, and be unemployed, compared to women, creating greater challenges for behavior change(Kalichman et al., 2009; Wechsberg et al., 2008).
  • Many donor agencies are only willing to invest in women (Pronyk et al., 2007; Yunus, 2003). Men havegreater interpersonal power, are considered to be substance abusers who squander money and unreliable employees, making interventions difficult (Khandker, 2005; Wong et al., 2008).
  •  Existing prevention programs are more consistent with women’s coping styles “to tend and befriend” (Taylor, 2002). Men’s coping style of fight-flight (Tyrell, 2002) is less compatible with HIV’s current arsenal of evidence-based interventions (EBI) and microfinance program support groups (Kuhanen, 2009). Men are unlikely to attend stigmatized counseling sessions, typical of EBI (Peterson, 2007).
  • The existing R3 billion spent on government job training programs in South Africa (i.e., SETA) deliver didactic lessons. Fewer than 0.9% get on-the-job training or graduate (Bennel & Segrestom, 1998; Akojee & McGrath, 2007; Ziderman, 2003). High demand for relatively low skilled labor is filled by immigrants from neighboring African countries, rather than South Africans, leading to high unemployment and civil unrest.

This R34 aims to design a structural, community-level intervention to sustain self-protective acts among young, South African men aged 18-25 years. A two-pronged intervention is planned to acquire skills-of-daily- living (through soccer) and job skills (through artisan apprenticeships). Over two years, we will demonstrate the feasibility, acceptability, and uptake of the intervention components and outcome measures. We aim to shift four behaviors of young men: to increase consistent habits-of-daily-living, provide job skills and to decrease substance use and HIV-related sexual risk. Young men will be invited to play soccer daily, with contingency management in one neighborhood and not in another neighborhood.  If youth are adherent to the program, they will be offered on-the-job-training and receive artisan tools at graduation.

We will proceed in two phases:

In Phase 1, qualitative interviews will elicit information on men’s developmental pathways. Sonke Gender Justice, a South African NGO advocating for men’s mobilization for gender equity and respect for women, will recruit and train coaches for a daily soccer program and Artisans to deliver a job training program. While soccer is intrinsically rewarding, this pilot will evaluate whether a strategy of behavioral economists (i.e., contingency management) is needed to ensure high program uptake to shape four daily routines: showing up on time, sober & drug free, completing practice, and showing sportsmanship. Coaches will not be counselors or provided with specific scripts, but will be trained in the Street Smart EBI to learn the core intervention tools to problem solve challenges of daily living; create opportunities to dramatically demonstrate key health principles; to form solid bonds with young men; and to be knowledgeable about health risks and community resources. The artisan trainers will be local entrepreneurs making an income, who will receive training and support on how to mentor youth. Artisans will be supported to shape youth’s job behaviors, similar to our successful Uganda program (Rotheram-Borus et al., 2010; Lightfoot et al., 2009).

In Phase 2, a quasi-experimental design with two neighborhoods will be implemented. Neighborhoods have been matched on size, type and quality of housing, number of shebeens (bars), and length of residence. All young men aged 18-25 years in each neighborhood will be recruited to participate in a baseline interview (n=60/neighborhood). One neighborhood will be randomized to the Contingency Management Condition (CMC; n=60 youth) and one to the Control Condition (CC; N=60 youth) and reassessed at 6 months. Coaches will implement the soccer program in both neighborhoods; youth demonstrating consistent habits at soccer for at least two months will be offered access to four months of artisan training. Stakeholder interviews (n=10 at baseline and end of program in each neighborhood) and observations at local shebeens (n= 2/month @ 5 shebeens per neighborhood) will also be conducted to monitor community-level changes over time.

The specific aims of this project are:

  1. To describe perceived challenges of emerging adulthood among young men; and to document perceptions of the program’s challenges and successes, and the key features of the social movement strategies of the Sonke Gender Justice NGO partner that are associated with men’s successes.
  2. To document the program uptake, adherence, prosocial acts, and substance free days in CM vs no-CM.
  3. To examine if young men in the CM vs. no-CM control condition demonstrate significantly:

a. Fewer HIV-related sexual risk acts, less substance use, and more employment;
b. More positive life goals; consistent, healthy daily routines; & greater social support & prosocial acts.
c. To contrast the number of men in shebeens and clean substance use screens across conditions.

Story of Champions League Player Yolani Benge - Report

NIMH Project Accept

Project Accept is a Phase III randomized controlled trial of community mobilization, mobile testing, same-day results, and post-test support for HIV in in sub-Saharan Africa and Thailand. Thirty-four communities in Africa (South Africa, Tanzania, and Zimbabwe) and 14 communities in Thailand are randomized to receive either a community-based HIV voluntary counseling and testing (CBVCT) intervention plus standard clinic-based VCT (SVCT), or SVCT alone. The CBVCT intervention has three major strategies: (1) to make VCT more available in community settings; (2) to engage the community through outreach; and (3) to provide post-test support. These strategies are designed to change community norms and reduce risk for HIV infection among all community members, irrespective of whether they participated directly in the intervention.

Research Methods:  

  • Community Engagement
  • Baseline Behavioral Assessment
  • Community Matching
  • Qualitative Assessment
    • Community Mapping and Ethnography
    • In-Depth Interviews
  • CBVCT Communities
    • Community Mobilization
    • Easy Access to VCT
    • Post-Test Support Services
    • Quality Assurance
  • Control Communities
    • Clinic-Based VCT
    • Quality Assurance
  • Post-Intervention Assessment
    • Post-Intervention Biological Assessment
    • Post-Intervention Behavioral Assessment
  • Cost-Effectiveness Analysis

From the perspective of national AIDS control planners in hard-hit countries, evidence-based strategies that have maximum epidemic impact are critically needed. These planners need interventions that are sustainable and can be adapted to the context of their local cultures. This is the first randomized controlled Phase III trial to determine the efficacy of a behavioral/social science intervention with an HIV incidence endpoint in the developing world. Provided that we can document efficacy with regard to HIV incidence and incremental cost-effectiveness, we expect that resources for widespread implementation of community-based VCT will become available from USAID or the Global Fund. We have worked closely with representatives of national AIDS programs in the host countries to ensure that the intervention is sustainable even in countries with limited resources.

 

Promoting Migrant Health Through HIV Awareness

For some Mexican migrants, the opportunities for receiving HIV-related interventions may be quite limited, especially for migrants who are in transition from one locale to another and who may not have the residential stability oftentimes required by HIV prevention programs.  Such transient populations may benefit from HIV prevention programs provided by individuals with similar backgrounds as theirs who are able to provide HIV-related information in informal one-on-one settings in the migrants’ own environments.  This project seeks to determine whether a peer education intervention with Mexican migrants is just as effective as a provider-based small group HIV prevention lecture as measured by the recipients’ HIV knowledge, HIV-related risk reduction skills, self-efficacy with respect to such skills, and intentions to engage in low-risk practices.

A total of 612 Mexican migrants will be recruited.  Mexican migrants from three migrant shelters in Mexicali will be trained as peer educators of a theory-driven HIV prevention intervention.  Each peer educator will conduct individual educational interventions with other Mexican migrants.  An outcome evaluation will be conducted to determine the extent to which those who received the peer education intervention differed from the recipients of the small group HIV prevention lecture with regards to the areas mentioned above and how both interventions differed from a no-treatment control group.

 

Testing of an HIV Prevention Card Game for the Angolan Armed Forces

Brief overview: The goals of this pilot study are to evaluate the effectiveness and cultural applicability of a game that promotes greater awareness of HIV/AIDS prevention messages.  By using a consumer driven approach and adapting innovations from computer and video gaming, a low-cost prevention tool can be produced and utilized throughout a resource-poor country that is threatened by rising HIV infections. Specifically, this proposal aims 1) To assess the added benefit of learning a novel, entertaining and culturally appropriate HIV prevention card game on HIV-related knowledge, attitudes and behaviors among Angolan soldiers receiving a standard HIV prevention intervention, and 2) To assess the diffusion of the game to others residing on the same base where the game is being taught and determine its impact on their HIV related knowledge, attitudes and behaviors.

Creating a culturally appropriate and enjoyable card game that promotes HIV/AIDS prevention has the potential to substantially increase awareness of risk behaviors and prevention methods in a high risk group. In the long-term, prevention materials that engage and entertain may have greater and longer lasting impact than other types of prevention strategies particularly in low resource settings where there are fewer opportunities for novel entertainment.

Geographical Location: Angola

Targeted risk group: Soldiers

Intervention Model: Randomized Control Trial

Research methods: Community-based randomize control trial with participants randomized to either an HIV prevention lecture or an HIV prevention lecture in which they are also taught to play the card game.  Knowledge of HIV assessed at pre- and post-intervention

Local and International significance: In very low resource settings with low literate populations, low cost, low tech prevention solutions that are culturally congruent may work best.  Among soldiers a card game that also teaches an HIV prevention message may be an effective strategy to increase knowledge of HIV and help reduce risk.

Assessing Sexual Social Networks of Black and Hispanic MSM/Ws in Los Angeles County

Nationally and locally Blacks and Latinos have the highest incidences of HIV/AIDS. When stratifying incidence by gender, Blacks and Latino women have higher rates of HIV infection compared to their White counterparts. A recent “mainstream” hypothesis for the rise in numbers among minority women is that Black and Latino men in concurrent secret sexual relationships with men and Black and Latina women are the “bridgers” of infection between the homosexual (MSM) community and the heterosexual community. Currently no scientific evidence of transmission trends supporting this hypothesis has been documented. Although inferences from surveys such as the Young Men’s Study have been proffered as proof, such studies do not show direct causation. Further, few scientific studies have analyzed the societal and cultural factors that could impact the decision of Black and Latino men to disclose their sexual practices or HIV seropositivity.

The research project involved a two phase mixed methods study (qualitative and quantitative) focusing on cultural, spiritual, racial and gender related factors that facilitate or impede the disclosure of Black and Latino men who have sex with men and women (MSM/W) of their sexual preference or HIV serostatus.

Phase 1 consisted of 9 focus groups with 4 participants each (n=36) and 12 focused interviews (n= 12). All interviewees completed a short survey after the focus group or interview. A racially concordant facilitator conducted each research session. Phase 2 utilized findings from Phase I to construct an ethnographic interview guide. Forty ethnographic interviews (10 African-American MSM/W, 10 Hispanic MSM/W and 20 of their adjacent or peripheral female sexual partners) were conducted.

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