- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02281578
Community-based Combination HIV Prevention in Tanzanian Women
Community-based Combination HIV Prevention in Tanzanian Women at Heightened Risk
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Iringa, Tanzania
- MUHAS
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Combination prevention
Community-based, combination HIV prevention intervention package
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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.
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Aktiv komparator: Standard of care
Locally run standard of care HIV prevention, treatment and care services
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Locally available standard of care HIV prevention, treatment and care services
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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HIV incidence
Tidsramme: 18 months
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Biologic assessment of new infections among HIV-uninfected participants via blood draw
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18 months
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Viral load suppression
Tidsramme: 18 months
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Biological assessment of viral suppression among HIV-infected participants via blood draw
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18 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Consistent condom use
Tidsramme: 18 months
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Consistent condom use with clients among all participants via survey measures
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18 months
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Adherence to ART
Tidsramme: 18 months
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Adherence to ART medication among those living with HIV via survey measures
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18 months
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Deanna L Kerrigan, PhD, MPH, Johns Hopkins Bloomberg School of Public Health
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- R01MH104044 (U.S. NIH-bevilling/kontrakt)
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