Innovations in HIV Testing

Not Applicable

Completed

• Conditions: Human Immunodeficiency Virus
• Interventions: Other: Oraquick HIV Self Test; Other: Clinic Based HIV Counseling and Testing (HCT)

• Registration Number: NCT03162965
• Lead Sponsor: University of North Carolina, Chapel Hill

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 Timeline

• Study Start: 2016-12-01
• Study First Submitted: 2017-05-19
• Study First Submitted QC: 2017-05-19
• Study First Posted: 2017-05-22
• Primary Completion: 2018-10-31
• Study Completion: 2018-10-31
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-06
• Last Update Posted: 2019-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 898

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Choice	Clinic Based HIV Counseling and Testing (HCT)	Oraquick HIV Self Test or Clinic Based HIV Counseling and Testing (HCT)
HIV Counseling and Testing	Clinic Based HIV Counseling and Testing (HCT)	Clinic Based HIV Counseling and Testing (HCT)
Choice	Oraquick HIV Self Test	Oraquick HIV Self Test or Clinic Based HIV Counseling and Testing (HCT)

Primary Outcome Measures

Name	Time	Method
Proportion of index reporting testing uptake	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 Outcome Measures

Name	Time	Method
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	Among participants who test positive (young women, peers and sex partners), the investigators will examine uptake of linkage to care.
Proportion of peer/partners reporting testing uptake	12 months post randomization	Compare between the two study arms the proportion of testing uptake by peers/partners. 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.
Proportion of peer/partner referrals by the index	12 months post randomization	Compare between the two studies arms the number of self test kits and HCT cards distributed by the index.

Trial Locations

Locations (1)

Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit; 🇿🇦 Acornhoek, Mpumalanga, South Africa