Clinical trial NCT03162965: Innovations in HIV Testing
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: 2017-05-22
Enrollment: 898
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants randomized to (1) Choice - they get to choose (1a) self-test vs (1b) HCT (HIV testing and counseling at clinic) or (2) they are randomized to HCT.
Primary purpose: SCREENING

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.

Eligibility criteria: Eligibility Inclusion Criteria Index:

* 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

Primary outcomes:
measure: Proportion of index reporting testing uptake
timeFrame: 3 months post randomization
Secondary outcomes:
measure: Proportion of peer/partner referrals by the index
timeFrame: 12 months post randomization
measure: Proportion of peer/partners reporting testing uptake
timeFrame: 12 months post randomization
measure: 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+
timeFrame: 12 months post randomization
Other outcomes:
Locations:
city: Acornhoek
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:
citation: Pettifor A, Lippman SA, Kimaru L, Haber N, Mayakayaka Z, Selin A, Twine R, Gilmore H, Westreich D, Mdaka B, Wagner R, Gomez-Olive X, Tollman S, Kahn K. HIV self-testing among young women in rural South Africa: A randomized controlled trial comparing clinic-based HIV testing to the choice of either clinic testing or HIV self-testing with secondary distribution to peers and partners. EClinicalMedicine. 2020 Apr 18;21:100327. doi: 10.1016/j.eclinm.2020.100327. eCollection 2020 Apr.
citation: Ritchwood TD, Selin A, Pettifor A, Lippman SA, Gilmore H, Kimaru L, Hove J, Wagner R, Twine R, Kahn K. HIV self-testing: South African young adults' recommendations for ease of use, test kit contents, accessibility, and supportive resources. BMC Public Health. 2019 Jan 29;19(1):123. doi: 10.1186/s12889-019-6402-4.