Innovations in HIV Testing

Conditions

Human Immunodeficiency Virus

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.

A. Pettifor, S.A. Lippman, L. Kimaru, N. Haber, Z. Mayakayaka et al. (14 authors)

UNC Libraries2020-12-181 citations

10.17615/c4zs-af15

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.

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.

2020-04-1869 citations

10.1016/j.eclinm.2020.100327

HIV self-testing: South African young adults’ recommendations for ease of use, test kit contents, accessibility, and supportive resources

Tiarney D. Ritchwood, Amanda Selin, Audrey Pettifor, Sheri A. Lippman, Hailey Gilmore et al. (10 authors)

UNC Libraries2019-08-18

10.17615/nrbh-mx87

HIV self-testing: South African young adults' recommendations for ease of use, test kit contents, accessibility, and supportive resources.

Ritchwood TD, Selin A, Pettifor A, Lippman SA, Gilmore H, Kimaru L, Hove J, Wagner R, Twine R, Kahn K.

2019-01-2945 citations

10.1186/s12889-019-6402-4

Interventions

OTHEROraquick HIV Self Test

This is an oral swab in home HIV test.

OTHERClinic Based HIV Counseling and Testing (HCT)

Receiving Counseling and Testing for HIV at the clinic.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

NONE

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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 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.

Countries

South Africa

Outcome results

None listed