Clinical trial NCT03271424: Innovations in HIV Testing (TI)
Official title: Innovations in HIV Testing to Enhance Care for Young Women and Their Peers and Partners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: University of Witwatersrand, South Africa
name: University of California, San Francisco
name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-09-05
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Qualitative focus group discussions (FGDs) with male and female community members aged 18 - 24

In-clinic observation of HIV self-testing and completion of a brief CAPI/ACASI interview with male and female community members aged 18 - 24
Primary purpose: OTHER

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: Study Description 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, explained in this submission, 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.

Eligibility criteria: FGD Inclusion Criteria:

* Females and males aged 18 - 24
* Able and willing to provide informed consent
* Residing in the selected villages

Observation Inclusion Criteria:

* Females and males aged 18 -24
* Able and willing to provide informed consent
* Residing in the selected villages
* Not known to be HIV positive (not reporting a previous positive test)

Primary outcomes:
measure: Qualitative Summaries of Participant Experience in Focus Group Discussions
timeFrame: 6 months post study start
measure: Quantitative Summaries of Participants Experience in Observation Sessions
timeFrame: 12 month post study start
Secondary outcomes:
Other outcomes:
Locations:
city: Agincourt
country: South Africa
facility: Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit
state: Mpumalanga
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Audrey Pettifor
role: PRINCIPAL_INVESTIGATOR
References: