Innovations in HIV Testing

University of North Carolina, Chapel Hill898 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

898

Conditions

Human Immunodeficiency Virus

Interventions

Oraquick HIV Self TestOTHER

This is an oral swab in home HIV test.

Clinic Based HIV Counseling and Testing (HCT)OTHER

Receiving Counseling and Testing for HIV at the clinic.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit

Acornhoek, Mpumalanga, South Africa

Outcomes

Primary Outcomes

Proportion of index reporting testing uptake

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.

Time frame: 3 months post randomization

Secondary Outcomes

Proportion of peer/partner referrals by the index

Compare between the two studies arms the number of self test kits and HCT cards distributed by the index.

Time frame: 12 months post randomization

Proportion of peer/partners reporting testing uptake

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.

Time frame: 12 months post randomization

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+

Among participants who test positive (young women, peers and sex partners), the investigators will examine uptake of linkage to care.

Time frame: 12 months post randomization

Data from ClinicalTrials.gov

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