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Community-based Combination HIV Prevention in Tanzanian Women

11. marts 2020 opdateret af: Deanna Kerrigan, Johns Hopkins Bloomberg School of Public Health

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

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.

Studieoversigt

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

Interventionel

Tilmelding (Faktiske)

496

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Combination prevention
Community-based, combination HIV prevention intervention package
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.
Aktiv komparator: Standard of care
Locally run standard of care HIV prevention, treatment and care services
Locally available standard of care HIV prevention, treatment and care services

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
HIV incidence
Tidsramme: 18 months
Biologic assessment of new infections among HIV-uninfected participants via blood draw
18 months
Viral load suppression
Tidsramme: 18 months
Biological assessment of viral suppression among HIV-infected participants via blood draw
18 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Consistent condom use
Tidsramme: 18 months
Consistent condom use with clients among all participants via survey measures
18 months
Adherence to ART
Tidsramme: 18 months
Adherence to ART medication among those living with HIV via survey measures
18 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Deanna L Kerrigan, PhD, MPH, Johns Hopkins Bloomberg School of Public Health

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. oktober 2015

Primær færdiggørelse (Faktiske)

8. januar 2018

Studieafslutning (Faktiske)

8. januar 2018

Datoer for studieregistrering

Først indsendt

29. oktober 2014

Først indsendt, der opfyldte QC-kriterier

30. oktober 2014

Først opslået (Skøn)

2. november 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. marts 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. marts 2020

Sidst verificeret

1. marts 2020

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • R01MH104044 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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