Living with HIV – CHIPTS – Center for HIV Identification, Prevention and Treatment Services

26Oct

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

26Oct

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

13Sep

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

20Mar

Doxycycline Prophylaxis or Incentive Payments to Reduce Syphilis among HIV-infected Men Who Have Sex with Men

This pilot study will investigate the feasibility of conducting a large, randomized trial comparing a structural intervention to contingency management to reduce incident syphilis infections in an especially high risk group: HIV+ men who have sex with men (MSM) who have had syphilis twice or more since their HIV diagnosis. Subjects will be randomized to receive either QD doxycycline as syphilis prophylaxis or a financial incentive to remain STI free.

We will : 1) measure adherence to study visits in both arms; 2) measure adherence to the prophylaxis regimen; 3) measure any changes in risk behaviors among study participants and 4) to the extent possible in a small pilot study of short duration, compare effectiveness of doxycycline with that of a monetary incentive for remaining STI free.

Targeted Risk Group

HIV+ men who have sex with men (MSM) who have had syphilis twice or more since their HIV diagnosis.

Intervention Model

Subjects will be randomized to receive either 1) Doxycycline, 100 mg. to be taken once daily or 2) an incentive for remaining STI free.

Local Significance

Results of this study can be used to inform public health policy and programs to reduce risk of STI and HIV transmission among HIV+ “core transmitters,” and can also be easily extended to HIV negative MSM with repeated STIs. With the preliminary data from this study we hope to apply for further funding to support a larger, multisite definitive study incorporating one or both of the current interventions.

29Feb

Uganda HIV Voluntary Counseling and Testing Study

The Uganda HIV Voluntary Counseling and Testing (VCT) Study is a randomized clinical trial to evaluate strategies for optimizing risk reduction within the context of routine HIV VCT (rVCT) and fully integrating inpatient counseling and testing with post-discharge HIV medical care to ensure that diagnosed individuals receive access to care.

The first intervention compares, in a non-inferiority study design, in-patient/outpatient routine counseling and testing (rVCT) with traditional HIV pre- and post-test counseling and testing (tVCT). The second intervention compares, in a superiority design, an “enhanced linkage to care” model for seropositive persons to increase uptake and long-term utilization of HIV-specific medical care compared to routine discharge and referral.

29Feb

Ai Shi Zi

Ai Shi Zi is a five-year NIMH-funded prevention and treatment study, the goal of which is to teach physicians how to enhance prevention and care for HIV and STIs. Because HIV and STIs are closely linked, prevention requires both state-of-the-art treatment and changes in sexual behavior. This study aims to teach physicians how to focus on both of these elements.

A total of 60 counties in China’s Anhui Province will be randomly assigned to one of two conditions: 1) primary and secondary training, in which county-level physicians are trained and, in turn, train township-level physicians; and 2) delayed-intervention control, in which physicians receive training only at the end of the 12-month assessment. Our primary endpoint is a hypothesized reduction in the one-year incidence of Chlamydia and gonorrhea among patients of trained county- and township-level physicians relative to delayed-intervention controls. Physicians and patients at the county- and township-levels will also be assessed using questionnaires at baseline and at 6 and 12 months following baseline.

Local significance (How has this project impacted the immediate population?):

This project provides training to county- and township-level physicians in Anhui Province, China and, hopefully, improved care and treatment to their patients at risk for STIs, including HIV.

International significance (How has this project impacted the global community?):

This study may provide a useful model for training of physicians in a variety of developing country settings who care for patients at risk for STIs, including HIV.

29Feb

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.

24Jan

Feasibility Study of a Community Level, Multi-Component, Intervention for Black MSM

To ascertain the feasibility and acceptability of an intervention among Black men who have sex with men (MSM), to prepare for a community-level randomized trial to test the efficacy of the intervention in reducing HIV incidence among Black MSM.

Approximately 2136 “first wave” participants (267 per site at eight sites) and approximately 400 referred partners (70 per site at six sites). There will be no limit on enrollment of participants referred by “index” participants already in the study (according to the referring scheme in the protocol). Index participants are defined later in the protocol, but can be generally described as those newly identified with HIV infection, those with previously diagnosed HIV infection who are not receiving HIV care, and certain HIV negative participants. Men enrolling for this study who have not been referred by an index participant will be called “first wave” participants. Enrollment of first wave participants will cease when 200 first wave participants eligible for longitudinal follow up have been enrolled. Enrollment of certain sub-categories of first wave participants will be limited according to criteria detailed in the protocol.

Treatment Regimen:

The intervention components provided to participants include: HIV risk-reduction counseling, testing and referral for care STI testing and referral for care Screening for substance use and mental health issues, and provision of counseling and referral for care (if indicated) Engagement with peer-health navigators to facilitate uptake of healthcare and other services Enumeration of up to 20 social and sexual network members by all participants and referral of up to 5 sexual partners by index participants for enrollment into the study

Primary Objectives:

To obtain information needed to design the full community-randomized trial, particularly in the areas of: recruitment of black MSM satisfaction of Black MSM with intervention components uptake of the intervention components by Black MSM, including: Proportion of enrolled participants who agree to HIV testing Proportion of participants who agree to STI testing Proportion of participants who utilize peer navigator referrals Proportion of HIV infected participants entering HIV care Increase in condom use in all participants from enrollment to week 52 Decrease in viral load among HIV infected participants from initiation of HAART to week 52 Decrease in STIs among all participants from enrollment to week 52

Secondary Objectives:

To collect samples, behavioral data and HIV test results to improve laboratory measures of HIV incidence based on samples derived from cross-sectional studies To estimate the HIV incidence rate and the effect of the intervention on the incidence rate through mathematical modeling To describe characteristics of sexual network members of black MSM who are newly diagnosed with HIV infection, or previously diagnosed but not in care To assess attitudes of black MSM toward other prevention interventions To describe social and sexual networks of Black MSM within cities to inform decisions about what constitutes a randomizable unit for a future trial of the intervention.

Study Sites:
• Atlanta: Emory University
• Boston: Fenway Community Health Center
• Los Angeles: University of California Los Angeles
• New York City: New York Blood Center/Harlem Hospital
• San Francisco: San Francisco Department of Public Health
• Washington DC: George Washington University

Interventions, Training Manuals, etc. :

[Download not found]

23Jan

Teens and Adults Learning to Communicate (TALC: LA)

Project TALC was funded by the National Institute of Mental Health (NIMH) to evaluate the efficacy of a family-based intervention over time and to contrast the life adjustments of HIV-affected families and their non-HIV-affected neighbors in the current treatment era. Mothers living with HIV (MLH; n = 339) and their school-age children (n = 259) were randomly assigned to receive a behavioral intervention or standard care as the control condition. MLH and their children were compared to non-HIV-affected families recruited at neighborhood shopping markets.

Targeted Risk Group:

HIV-positive mothers and their adolescent children

Published Journal Articles:

[Download not found]
[Download not found]
[Download not found]
[Download not found]
[Download not found]
[Download not found]
[Download not found]
[Download not found]
[Download not found]
[Download not found]
[Download not found]
[Download not found]

Links to Interventions, Training Manuals, etc. :

Phase 1 – Taking Care Of Myself

Parents’ Curriculum

Phase 2 – Illness

Parents’ Curriculum

Adolescents’ Curriculum

Phase 3 – Adjustment

New Caregivers and Teens’ Curriculum

Young Adults’ Curriculum

Intervention Model:

Mothers and their adolescents attended a 16-session cognitive behavioral intervention over eight weeks. For MLH, intervention goals aimed to: 1) improve parenting while ill (i.e., reduce family conflict, improve communication, clarify family roles); 2) reduce mental health symptoms; 3) reduce sexual and drug transmission acts; and 4) increase medical adherence and assertiveness with medical providers. For adolescents, the intervention goals were to: 1) improve family relationships; 2) reduce mental health symptoms; 3) reduce multiple problem behaviors (e.g., drug use, criminal justice acts, school problems, teenage pregnancy); and 4) school retention.

Research Methods:

In a random assignment study, families assigned to take part in Project TALC were compared with families assigned to a control group on mental health and health behaviors, including sexual behavior and substance use. Both intervention and control families were compared to a neighborhood cohort, matched on sociodemographics. Because study participants were followed over two years, longitudinal random effect regression models were used to test the efficacy of the intervention.

Surveys and Scales Used:

Local Significance:

There was a lack of significant findings for an intervention effect on HIV-transmission behaviors and mental health. HIV-transmission behaviors were low to begin with and participants had little room for improvement. The populations affected by the HIV epidemic in the U.S. have shifted over the past number of years since a similarly mounted intervention in New York City led to improvements. HIV interventions in the U.S. need to shift their focus to persons living with HIV who are experiencing substantial problems.

International Significance:

While the focus of U.S.-based HIV interventions need to shift, interventions for the general HIV population may be effective outside the U.S.

23Jan

Together Learning Choices (TLC)

TLC (Together Learning Choices) is an HIV prevention and health promotion intervention developed for HIV-positive teens and youth (ages 13 to 29). TLC is delivered in small groups using cognitive-behavioral strategies to change behavior. It provides young people living with HIV the tools and skills necessary to live their best lives and to be able to make healthy choices. The goal of the intervention is to help these young people maintain health, reduce transmission of HIV and infectious diseases, and improve their quality of life. TLC is a product of extensive collaboration among researchers, staff from public and private agencies serving the population, and members of the intended population, representing diverse backgrounds and perspectives.

TLC consists of two sequential modules that totaled 16 sessions. Each module has eight sessions and is designed to be delivered by two Facilitators in a group setting.

The Staying Healthy module encourages healthy living by focusing on health maintenance and forging effective partnerships with health care providers.
The Acting Safe module is dedicated to primary and secondary HIV prevention by addressing sex- and substance use-related risk behaviors and reducing new infections and reinfections.

– The goal of this study was to design, pilot test, and evaluate an intervention for service providers to address HIV-related stigma and its impact on health service delivery and adequate care.
TLC is a science-based behavioral intervention that has demonstrated evidence of effectiveness in reducing risky behaviors, such as unprotected sex, or in encouraging safer ones, such as using condoms and other methods of practicing safer sex. It is offered by the Centers for Disease Control and Prevention (CDC) through the Replicating Effective Programs (REP) and Dissemination of Effective Behavioral Interventions (DEBI) at www.effectiveinterventions.org.

Targeted Risk Group:
Young People Living with HIV (YPLH) aged 13 to 24 in original efficacy trial and aged 13-29 in . The majority of participants were African-American and Latino.

Intervention model:
Small group intervention.
Original intervention manuals available here:

Module 1 – Staying Healthy

Module 2 – Act Safe: Sexual Decisions of HIV-Positive Youth and Reducing Drug and Alcohol Use

Module 3 – Being Together

CDC funded replication manual: TLC Implementation Manual
TLC Broadsheet

Research Methods:
Group randomized trial with immediate intervention and delayed (waitlisted) control conditions. Assessment interviews conducted every three months over 24 months.

Local Significance:
The intervention reduced sexual risk behaviors, substance use, and emotional distress, and increased social support and other positive coping styles.