HPTN 063
Preparing for international prevention trials involving HIV-infected individuals in care settings
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What is HPTN 063?
HPTN 063 was a research study to conduct the preparatory research needed to design a behavioral intervention to decrease sexual transmission risk behaviors in HIV-infected individuals in care and to determine whether a similar intervention structure could be used across various sexual risk groups and cultural settings.
Who participated in the study?
A total of 751 HIV-infected participants (200 MSM in Brazil and Thailand, 300 heterosexual women, and 251 heterosexual men in Brazil, Thailand and Zambia, who had reported recent (within in the last three months) HIV sexual transmission risk behavior.
What happened during the study?
Study participants were enrolled to complete five quarterly quantitative surveys over the course of a year, and provided specimens for sexually transmitted infection analysis. A subset of participants was enrolled for qualitative interviews including community members/stakeholders and a subset of the HIV-infected participants from the quantitative survey.
Results
By comparing the data across the sites and risk groups, we identified commonalities and variations in participants’ sexual practices, attitudes towards sex, and sexual relationships. The results of these qualitative data are presented according to three themes: (1) protective behaviors; (2) barriers to engaging in sexual safety; and (3) HIV stigma and sexual partnerships.
- Participants described many changes in their sexual behavior as a consequence of becoming infected with HIV, including: reduction in sexual activity; increased focus on condom use; and engagement in lower-risk sexual activities. While several shared experiences across the three risk groups (MSW, WSM, and MSM) and sites (Brazil, Thailand, and Zambia) emerged, the data also reflected some notable distinctions.
- Most of the participants found consistent condom use to be challenging. One of the primary sources of difficulty was that casual and primary sex partners viewed condomless sex as ‘normal’.
- Individuals living with HIV/AIDS at all sites discussed the effects of HIV on relationships with sex partners. HIV stigma was the most common thread in discussions about relationships with sex partners. A significant theme, especially among WSM, was the need to avoid primary intimate sexual relationships because of worry about how a past or potential partner would react after HIV status disclosure.
Protocol Status
Concluded
Study Purpose
To conduct preparatory research needed to design a behavioral intervention to decrease sexual transmission risk behaviors in HIV-infected individuals in care and to determine whether a similar intervention structure can be used across various sexual risk groups and cultural settings.
Study Design
Multi-site, observational, cohort study (quantitative component). In-depth interviews and focus groups (qualitative component).
Study Population
HIV-infected men and women in Africa (Zambia), Asia (Thailand), and South America (Brazil), who have reported recent (within 3 months) HIV sexual transmission risk behavior.
Study Size
800 quantitative (HIV-infected) participants: 300 heterosexual men (100 per site), 300 heterosexual women (100 per site), 200 MSM (100 per site in Asia and South American sites only); approximately 120 qualitative participants (community members/stakeholders; 40 from each site, a subset of the HIV-infected participants will also participate in qualitative individual interviews).
Study Duration
Approximately two years total: One year for participant accrual. Participants will be followed for one year with interviews and assessments quarterly. Qualitative assessment will occur during this 2 year time frame.
Treatment Regime
This is an observational study.
Primary Objectives
1) To establish baseline rates of sexual HIV transmission risk behavior in high risk, HIV-infected individuals, and to observe the rates and patterns of behavioral change over time.
2) To gather formative data on the potential structure and content of a behavioral intervention for individuals with HIV in care in international settings and to determine the best, culturally appropriate model for the intervention that will link prevention to care for HIV-infected individuals.
3) To examine potential psychosocial and sociodemographic correlates of sexual risk taking in these individuals in order to help shape the content of an individualized behavioral intervention.
Secondary Objectives
Evaluate STI prevalence and incidence and investigate whether these biomarkers may be used to corroborate self-reported sexual behavior associated with potential transmission risks