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Community-based Combination HIV Prevention in Tanzanian Women

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ClinicalTrials.gov Identifier: NCT02281578
Recruitment Status : Active, not recruiting
First Posted : November 3, 2014
Last Update Posted : March 7, 2017
Sponsor:
Collaborator:
Muhimbili University of Health and Allied Sciences
Information provided by (Responsible Party):
Deanna Kerrigan, Johns Hopkins Bloomberg School of Public Health

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.

Condition or disease Intervention/treatment Phase
HIV Behavioral: Community-based combination HIV prevention intervention Behavioral: Standard of care HIV services Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Community-based Combination HIV Prevention in Tanzanian Women at Heightened Risk
Study Start Date : January 2015
Estimated Primary Completion Date : June 30, 2017
Estimated Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Combination prevention
Community-based, combination HIV prevention intervention package
Behavioral: Community-based combination HIV prevention intervention
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.

Active Comparator: Standard of care
Locally run standard of care HIV prevention, treatment and care services
Behavioral: Standard of care HIV services
Locally available standard of care HIV prevention, treatment and care services




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02281578


Locations
Tanzania
MUHAS
Iringa, Tanzania
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Muhimbili University of Health and Allied Sciences
Investigators
Principal Investigator: Deanna L Kerrigan, PhD, MPH Johns Hopkins Bloomberg School of Public Health

Responsible Party: Deanna Kerrigan, Associate Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT02281578     History of Changes
Other Study ID Numbers: R01MH104044 ( U.S. NIH Grant/Contract )
First Posted: November 3, 2014    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017

Keywords provided by Deanna Kerrigan, Johns Hopkins Bloomberg School of Public Health:
Sex Workers
Prevention