Innovations in HIV Testing

Human Immunodeficiency Virus Clinical Trial

— TI  

Official title:

Innovations in HIV Testing to Enhance Care for Young Women and Their Peers and Partners

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03162965
• Other study ID #: 15-1361b
• Secondary ID: 5R01HD083033
• Status: Completed
• Phase: N/A
• Start date: December 1, 2016
• Est. completion date: October 31, 2018

Study information

• Verified date: August 2019
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 898
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

Other:
• Oraquick HIV Self Test
This is an oral swab in home HIV test.
• Clinic Based HIV Counseling and Testing (HCT)
Receiving Counseling and Testing for HIV at the clinic.

Locations

Country	Name	City	State
South Africa	Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit	Acornhoek	Mpumalanga

Sponsors (5)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), University of California, San Francisco, University of Witwatersrand, South Africa

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months post randomization
Secondary	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.	12 months post randomization
Secondary	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.	12 months post randomization
Secondary	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.	12 months post randomization