Acceptability, Feasibility and Impact of Oral HIV Self-testing for Partner Testing Among Kenyan Adolescent Girls Aged 15-19 Years: A Randomized Controlled Trial

NCT04805112 | Completed

• 1 other identifier: 848410
• Study Type: interventional
• Target: 349
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial will assess the feasibility, acceptability and impact of the provision of multiple oral-fluid based HIV self-test kits to HIV-negative adolescents aged 15-19 years to promote HIV testing among their sexual partners and couples testing.

Conditions

Human Immunodeficiency Virus

Keywords

HIV self-testing; partner testing; couples testing; transactional sex; young women; adolescent girls; female sex workers

Outcome Measures

Primary Outcomes (1)

• uptake of partner HIV testing

  proportion of partners that complete HIV testing

  3 months

Secondary Outcomes (8)

• Introduce testing

  3 months

• Partner accept testing

  3 months

• Partner testing

  3 months

• Couples testing

  3 months

• Positive partner

  3 months

Study Arms (2)

Provision of multiple self-tests

EXPERIMENTAL

Participants randomized to the intervention group will be given 2-3 HIV oral self-tests to offer to their sexual partner(s). The participant will be instructed to encourage their partner to test himself alone \[partner testing\] or with the participant \[couple testing\]; the partner will also be given a card with information on testing and a list of facilities where he can go for confirmatory testing. All participants will be encouraged to call a study helpline/hotline in the event of any adverse events that they or their sexual partners experience or if they need further instructions or information

Behavioral: Provision of multiple self-tests

Referral vouchers for clinic testing

NO INTERVENTION

Participants randomized to the control group will be given multiple referral coupons for HIV testing at pre-selected HIV testing services (HTS) sites. The participant will be instructed to give the coupon to their sexual partner(s) and encourage him to go for HIV testing at pre-selected HTS sites, either alone \[partner testing\] or together with the participant \[couple testing\]. The coupon will also have information on testing and a list of facilities where he can go for HTS. All participants will be encouraged to call a study helpline/hotline in the event of any adverse events that they or their sexual partners experience or if they need further instructions or information

Interventions

Provision of multiple self-tests BEHAVIORAL

Participants will be given multiple Oraquick Advance HIV-1/2 test kits to distribute to their sexual partners for partner testing or couple testing. Phone interviews will be conducted with the participants to assess whether they provided a HIV self-test to their partner, if the test was used, how it was used (partner testing or couple testing), if the partner disclosed his results, the partner's reaction to the results, and if the partner went for confirmatory testing

Provision of multiple self-tests

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Female
• Aged 15-19 years
• HIV-negative (willing to self-test onsite in the presence of the Research Assistant who is also a trained HIV counselor)
• Has at least one current sexual partner she expects to meet at least twice in the next 3 months (not necessarily to have sex); this will provide opportunity for the participant to suggest/offer testing.
• Resides in Siaya County and does not intend to relocate within 6 months from enrollment, to allow follow up to be completed and to conduct IDI with those selected.
• Willing to be randomized into the partner self-testing or HTS referral groups.
• Reporting no incident of sexual, physical, emotional, or economic abuse in the last 12 months from the partner she intends to offer (Appendix 4) or refer for testing (Appendix 3) in the next 3 months and does not believe the partner will abuse her if she offers the self-test kits or HTS referral coupon.
• Has a male partner who has not tested for 6 months or whose HIV status is unknown to her.
• Agrees to give consent to participate in the study.

You may not qualify if:

• Male
• HIV-positive
• Not willing to self-test onsite under in the presence of the Research Assistant
• Aged \<15 years or \>19 years
• Does not have a current sexual partner or does not expect to meet the partner at least twice in the next 3 months
• Does not reside in Siaya County or intends to relocate within the next 6 months
• Not interested in obtaining HIV self-tests or HTS referral coupon for purposes of suggesting testing to their sexual partners
• Reporting an incidence of sexual, physical, emotional or economic abuse in the last 12 months from the partner she would have offered self-test kit or referred for testing, or believes the partner may subject her to sexual, physical, emotional, or economic abuse if she offered them self-test kit or HTS coupon.
• Has a male partner who tested within the last 6 months.
• Does not give consent to participate in the study

Sponsors & Collaborators

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

Study Sites (1)

Impact Research & Development Organization

Kisumu, Kenya

Location

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

Study Officials

• Kawango Agot, PhD

  Impact Organization & Research Development

  PRINCIPAL INVESTIGATOR

• Harsha Thirumurthy, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

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: Participants will be recruited through the DREAMS (Determined, Resilient, Empowered, AIDS-Free, Mentored, Safe) program being implemented in Siaya County, western Kenya, as well as other community groups and venues, by the host institution (Impact Research and Development Organization, IRDO). Participants will be randomized in a 1:1 ratio to either an intervention group (receive multiple oral HIV self-test kits) or control (receive referral vouchers for clinic based testing). About 300 women will be recruited to patriciate in this study.

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 18, 2021
• Study Start: March 2, 2021
• Primary Completion: April 19, 2021
• Study Completion: July 2, 2021
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)