Skip to main content
OpenTrials
Completed

NCT Number: NCT03162965

Innovations in HIV Testing

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Acornhoek, Mpumalanga, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oraquick HIV Self Test

Other

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.

Primary outcomes

  1. Proportion of index reporting testing uptake

    Time frame: 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 outcomes

  1. Proportion of peer/partner referrals by the index

    Time frame: 12 months post randomization

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

  2. Proportion of peer/partners reporting testing uptake

    Time frame: 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.

  3. 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+

    Time frame: 12 months post randomization

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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: TI

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 22, 2017
Registry last updated
Aug 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.