Innovations in HIV Testing to Enhance Care for Young Women and Their Peers and Partners
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 898
- Locations
- 1
- Primary Endpoint
- Proportion of index reporting testing uptake
Study Overview
Brief Summary
The investigators propose to improve HIV prevention and care through expanding HIV testing options to include self-testing for young women, their peers and their sex partners, and by facilitating linkage to care.
Detailed Description
The investigators propose to improve HIV prevention and care through expanding HIV testing options to include self-testing for young women, their peers and their sex partners, and by facilitating linkage to care. In this study the investigators proposed two phases. The first phase, previously completed, is formative and involved two parts: 1) conducting formative qualitative research to understand perceptions of HIV testing and HIV self-testing in the study population and 2) conducting observed HIV self-testing to better understand any challenges with self-testing and the materials needed to make the process clear. The second phase of the study is a randomized controlled trial where the investigators will randomize approximately 400 young women to receive either 1) CHOICE of self-testing or clinic-based HIV Counseling and Testing (HCT) or 2) clinic based HCT. Once young women have been randomized, they will be asked to recruit up to 4 peers or male sex partners to test with the method of their randomization group.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Females ages 18-26
- •Have had sex in the past 3 months and plan to have sex again in the next 3 months
- •Planning on staying in the Agincourt Health and Demographic Surveillance System (AHDSS) area for the next nine months
- •Able and willing to provide informed consent
- •Willing to comply with study procedures
- •Not known to be HIV positive (not reporting a previous positive test)
- •Eligibility Inclusion Criteria Peer/Partner:
- •Females and Males ages 18 and older
- •Able and willing to provide informed consent
- •Willing to comply with study procedures
Exclusion Criteria
- Not provided
Arms & Interventions
Choice
Oraquick HIV Self Test or Clinic Based HIV Counseling and Testing (HCT)
Intervention: Oraquick HIV Self Test (Other)
Choice
Oraquick HIV Self Test or Clinic Based HIV Counseling and Testing (HCT)
Intervention: Clinic Based HIV Counseling and Testing (HCT) (Other)
HIV Counseling and Testing
Clinic Based HIV Counseling and Testing (HCT)
Intervention: Clinic Based HIV Counseling and Testing (HCT) (Other)
Outcomes
Primary Outcomes
Proportion of index reporting testing uptake
Time Frame: 3 months post randomization
Compare between the two study arms the proportion of testing uptake at 3 months post-randomization. Testing uptake is defined for HCT as self-report of going to the clinic and testing; and for self-test as self-report of using a self-test kit.
Secondary Outcomes
- Proportion of index and peer/partners who obtain a confirmatory test, start Antiretroviral Treatment (ART) if HIV+, and obtain their Cluster of Differentiation 4 (CD4) count if HIV+(12 months post randomization)
- Proportion of peer/partners reporting testing uptake(12 months post randomization)
- Proportion of peer/partner referrals by the index(12 months post randomization)