Secondary Distribution of HIV Self-tests: an Innovative Strategy for Promoting Partner Testing and Reducing HIV Risk

NCT03135067 | Completed Results DMC

• 2 other identifiers: 828100R01MH111602
• Study Type: interventional
• Target: 2,102
• Locations: 1 country
• Sites: 1

Brief Summary

This cluster randomized trial will assess whether the provision of multiple oral-fluid based HIV self-test kits to HIV-negative women at high risk of acquiring HIV in western Kenya is an approach that promotes HIV testing among women's sexual partners, facilitates better sexual decision making, and reduces women's risk of acquiring HIV.

Conditions

Human Immunodeficiency Virus

Keywords

HIV self-testing; female sex workers; partner testing; couples testing; transactional sex

Outcome Measures

Primary Outcomes (1)

• HIV Incidence Per 100 Person Years

  HIV incidence over an average follow-up period of 18 months, and up to 24 months, per 100 person years

  up to 24 months

Secondary Outcomes (5)

• Identification of HIV-positive Male Partners

  up to 24 months

• Used Condom With at Least One Partner After Partner Refused Self-test or HIV Testing Services Referral Card, or Tested HIV-positive

  Data was measured longitudinally up to 24 months for some subjects; all participants were measured through 18 months. Measures reported are from 18 month follow-up for behavior occurring in the past 6 months.

• Couples Testing With Primary Partner

  Data was measured longitudinally up to 24 months for some subjects; all participants were measured through 18 months. Measures reported are from 18 month follow-up for behavior occurring in the past 6 months.

• Primary Partner Tested for HIV

  Data was measured longitudinally up to 24 months for some subjects; all participants were measured through 18 months. Measures reported are from 18 month follow-up for behavior occurring in the past 6 months.

• Declined Sex With at Least One Partner After Partner Refused Self-test or HIV Testing Services Referral Card, or Tested HIV-positive

  Data was measured longitudinally up to 24 months for some subjects; all participants were measured through 18 months. Measures reported are from 18 month follow-up for behavior occurring in the past 6 months.

Other Outcomes (1)

• Intimate Partner Violence (IPV)

  Data was measured longitudinally up to 24 months for some subjects; all participants were measured through 18 months. Measures reported are from 18 month follow-up for behavior occurring in the past 6 months.

Study Arms (2)

Provision of multiple self-tests

EXPERIMENTAL

Participants in intervention clusters will be given multiple HIV self-test kits, testing instructions, and advice to use their discretion when offering self-tests to selected sexual partners. Participants will be encouraged to offer self-tests primarily to current and potential partners with whom unprotected sex is likely. All participants will be encouraged to use condoms with sexual partners. Participants will also be advised to assess the risk of intimate partner violence (IPV) as a result of offering self-tests to partners. Participants will have opportunities to obtain additional HIV self-test kits on a monthly basis.

Behavioral: Provision of multiple self-tests

Referral vouchers for VCT

NO INTERVENTION

Participants will be given a multiple referral vouchers for HIV testing to distribute to their sexual partners. All participants will be encouraged to use condoms with sexual partners. These referral vouchers will encourage the partners to seek HIV counseling \& testing services in local clinics. Participants will also be advised to assess the risk of intimate partner violence (IPV) as a result of offering referral vouchers to partners. Participants will have opportunities to obtain additional referral vouchers on a monthly basis.

Interventions

Provision of multiple self-tests BEHAVIORAL

Participants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for offering to selected sexual partners. The self-test kits will be given to participants on a monthly basis as needed. The intervention is designed to facilitate partner and couples testing, with resulting reduction in risky sexual behavior and HIV incidence among participants.

Provision of multiple self-tests

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old
• Currently resides in the study area
• Has resided in the study area for at least 6 months in the year prior to enrollment
• Intends to stay in the study area for at least 24 months
• Reports two or more sexual partners within the past 4 weeks at time of screening
• HIV negative
• Ownership or access to a mobile phone
• Willing and able to provide informed consent

You may not qualify if:

• Younger than 18 years old
• Does not currently live in the study area or has not for 6 of the last 12 months, or does not plan to for at least the next 24 months
• Fewer than two sexual partners in the last four weeks at time of screening
• HIV positive
• Has no access to a mobile phone
• Enrolled in another HIV prevention study
• Cannot or will not provide informed consent

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Mental Health (NIMH): collaborator
• Impact Research & Development Organization: collaborator
• RTI International: collaborator
• University of North Carolina: collaborator

Study Sites (1)

Impact Research and Development Organization

Kisumu, Kenya

Location

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• Ruderman LW, Ochwal P, Marcus N, Napierala S, Thirumurthy H, Agot K, Maman S. 'When I have these kits ... I have confidence' - HIV self-testing provides agency for women in their sexual decision-making. Glob Public Health. 2022 Dec;17(12):3735-3746. doi: 10.1080/17441692.2022.2092176. Epub 2022 Jun 30.

  PMID: 35770697 DERIVED

• Thirumurthy H, Bair EF, Ochwal P, Marcus N, Putt M, Maman S, Napierala S, Agot K. The effect of providing women sustained access to HIV self-tests on male partner testing, couples testing, and HIV incidence in Kenya: a cluster-randomised trial. Lancet HIV. 2021 Dec;8(12):e736-e746. doi: 10.1016/S2352-3018(21)00248-4.

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• Napierala S, Bair EF, Marcus N, Ochwal P, Maman S, Agot K, Thirumurthy H. Male partner testing and sexual behaviour following provision of multiple HIV self-tests to Kenyan women at higher risk of HIV infection in a cluster randomized trial. J Int AIDS Soc. 2020 Jun;23 Suppl 2(Suppl 2):e25515. doi: 10.1002/jia2.25515.

  PMID: 32589354 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Harsha Thirumurthy
• Organization: University of Pennsylvania

hthirumu@upenn.edu

215-746-0410

Study Officials

• Harsha Thirumurthy, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Female sex worker hotspots and beach communities in the Nyanza region of Kenya will be grouped into clusters that will be randomly assigned to receive the intervention (provision of multiple HIV self-test kits over time) or control (provision of clinic-based HIV testing referral vouchers over time). About 66 clusters, with an average of 30 participants per cluster, will be selected for the study.

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: May 1, 2017
• Study Start: June 4, 2017
• Primary Completion: March 25, 2020
• Study Completion: March 25, 2020
• Last Updated: December 16, 2022
• Results First Posted: December 16, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)