Status:
COMPLETED
Acceptability, Feasibility and Impact of Oral HIV Self-testing for Partner Testing Among Kenyan Adolescent Girls Aged 15-19 Years: A Randomized Controlled Trial
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Impact Research & Development Organization
National Institute of Mental Health (NIMH)
Conditions:
Human Immunodeficiency Virus
Eligibility:
FEMALE
15-19 years
Phase:
NA
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 ...
Detailed Description
This study will recruit HIV-negative adolescents girls (AG) aged 15-19 years in Siaya County, western Kenya. The study will evaluate the impact of the provision of oral HIV self-testing on uptake of t...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
March 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 2 2021
Estimated Enrollment :
349 Patients enrolled
Trial Details
Trial ID
NCT04805112
Start Date
March 2 2021
End Date
July 2 2021
Last Update
July 20 2022
Active Locations (1)
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1
Impact Research & Development Organization
Kisumu, Kenya