Clinical trial NCT02281578: Community-based Combination HIV Prevention in Tanzanian Women
Official title: Community-based Combination HIV Prevention in Tanzanian Women at Heightened Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Sex Workers
Prevention
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Muhimbili University of Health and Allied Sciences
First posted: 2014-11-02
Enrollment: 496
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. 18 years old, female, exchange sex for money in entertainment venue
2. key informants working on HIV among sex workers in the region.

Exclusion Criteria:

* Psychiatric/psychological condition impeding informed consent.

Primary outcomes:
measure: HIV incidence
timeFrame: 18 months
measure: Viral load suppression
timeFrame: 18 months
Secondary outcomes:
measure: Consistent condom use
timeFrame: 18 months
measure: Adherence to ART
timeFrame: 18 months
Other outcomes:
Locations:
city: Iringa
country: Tanzania
facility: MUHAS
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Deanna L Kerrigan, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kerrigan D, Mbwambo J, Likindikoki S, Davis W, Mantsios A, Beckham SW, Leddy A, Shembilu C, Mwampashi A, Aboud S, Galai N. Project Shikamana: Community Empowerment-Based Combination HIV Prevention Significantly Impacts HIV Incidence and Care Continuum Outcomes Among Female Sex Workers in Iringa, Tanzania. J Acquir Immune Defic Syndr. 2019 Oct 1;82(2):141-148. doi: 10.1097/QAI.0000000000002123.
citation: Kerrigan D, Mbwambo J, Likindikoki S, Beckham S, Mwampashi A, Shembilu C, Mantsios A, Leddy A, Davis W, Galai N. Project Shikamana: Baseline Findings From a Community Empowerment-Based Combination HIV Prevention Trial Among Female Sex Workers in Iringa, Tanzania. J Acquir Immune Defic Syndr. 2017 Jan 1;74 Suppl 1(Suppl 1):S60-S68. doi: 10.1097/QAI.0000000000001203.
citation: Beckham SW, Mantsios A, Galai N, Likindikoki S, Mbwambo J, Davis W, Kerrigan D. Acceptability of multiple modalities of pre-exposure prophylaxis (PrEP) among female sex workers in Tanzania: a mixed-methods study. BMJ Open. 2022 Aug 17;12(8):e058611. doi: 10.1136/bmjopen-2021-058611.