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Completed

NCT Number: NCT02281578

Community-based Combination HIV Prevention in Tanzanian Women

The Phase II trial will assess the feasibility, acceptance, safety, pathways, and initial effectiveness of a community-based combination HIV prevention intervention among bar-based female sex workers in Iringa, Tanzania. Results will inform an appropriately powered Phase III RCT as warranted.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MUHAS

Iringa, Tanzania

About this study

Combination HIV prevention demonstrates significant promise in reducing burden of disease. To maximize its effectiveness combination prevention must be tailored to a given context and population. From the beginning of the global HIV epidemic, female sex workers (FSWs) have been found to be at heightened risk for infection. More recently the role that sex work plays in ongoing HIV transmission dynamics has been more clearly established in generalized epidemics, where previously limited attention was paid to the role of key populations. The greater vulnerability of FSWs is now widely understood to be associated with social and structural factors including the intense stigma, discrimination and violence they often face and the unsafe environments in which they live and work. These factors are known to limit both protective sexual behaviors and engagement in HIV testing, care and treatment services. Comprehensive, community-based HIV prevention approaches addressing the aforementioned social and structural vulnerabilities to HIV infection among FSWs have been shown to be effective in South Asia and in Latin America. However, in sub-Saharan Africa where the impact of HIV is the greatest, no systematic efforts to develop and evaluate the feasibility and effectiveness of community-based combination HIV prevention among FSWs has occurred.

The investigators will conduct a two-arm Phase II community randomized controlled trial of a community-based combination HIV prevention intervention among FSWs in Iringa, Tanzania. The model was developed on the basis of prior formative research and mapping and utilizes an ongoing research infrastructure. The combination package will include integrated biomedical, behavioral and structural components: (1) mobile HIV testing and risk reduction counseling; (2) service navigation to facilitate access to treatment and retention in care; (3) sensitivity training for HIV clinical care providers; (4) SMS text messages to promote adherence to care and ART; (5) venue-based peer education and condom distribution; and (6) a community drop-in-center to promote cohesion and collective action to reduce stigma and discrimination. The investigators seek to establish base rates of key outcomes including HIV incidence and viral load suppression, examine the socio-structural and behavioral pathways of the intervention, assess feasibility, acceptability and safety, and document preliminary effectiveness. Should compelling indications of safety, feasibility, acceptability and initial effectiveness be found, study results will inform the first Phase III RCT of community-based combination HIV prevention among FSWs.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years old, female, exchange sex for money in entertainment venue
  • key informants working on HIV among sex workers in the region.

Exclusion criteria

  • Psychiatric/psychological condition impeding informed consent.

Treatment and study plan

Community-based combination HIV prevention intervention

Behavioral

The combination package will include integrated biomedical, behavioral and structural components: (1) mobile HIV testing and risk reduction counseling; (2) service navigation to facilitate access to treatment and retention in care; (3) sensitivity training for HIV clinical care providers; (4) SMS text messages to promote adherence to care and ART; (5) venue-based peer education and condom distribution; and (6) a community drop-in-center to promote cohesion and collective action to reduce stigma and discrimination.

Standard of care HIV services

Behavioral

Locally available standard of care HIV prevention, treatment and care services

Primary outcomes

  1. HIV incidence

    Time frame: 18 months

    Biologic assessment of new infections among HIV-uninfected participants via blood draw

  2. Viral load suppression

    Time frame: 18 months

    Biological assessment of viral suppression among HIV-infected participants via blood draw

Secondary outcomes

  1. Consistent condom use

    Time frame: 18 months

    Consistent condom use with clients among all participants via survey measures

  2. Adherence to ART

    Time frame: 18 months

    Adherence to ART medication among those living with HIV via survey measures

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Muhimbili University of Health and Allied Sciences

Registry information

Official study title

Community-based Combination HIV Prevention in Tanzanian Women at Heightened Risk

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Nov 3, 2014
Registry last updated
Mar 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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