Clinical trial NCT04805112: Acceptability, Feasibility and Impact of Oral HIV Self-testing for Partner Testing Among Kenyan Adolescent Girls Aged 15-19 Years: A Randomized Controlled Trial
Official title: Acceptability, Feasibility and Impact of Oral HIV Self-testing for Partner Testing Among Kenyan Adolescent Girls Aged 15-19 Years: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Keywords: HIV self-testing
partner testing
couples testing
transactional sex
young women
adolescent girls
female sex workers
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Impact Research & Development Organization
name: National Institute of Mental Health (NIMH)
First posted: 2021-03-18
Enrollment: 349
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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 testing among partners of adolescent girls. We will randomize about 300 sexually active AG to either an intervention group that receives multiple oral self-test kits that they can choose to offer to their sexual partner(s) or to a control group that will be given multiple referral coupons that their partners can use for HIV testing at pre-selected HIV testing services (HTS) sites. We will collect data on whether the kits were offered, to whom they were offered, if they were accepted, if they were used and with what results, if known, and if the partners who obtained HIV-positive results sought confirmatory testing. We will also conduct in-depth interviews with a sub-set adolescents to explore their experiences in offering HIV self-testing to their male partners.

This study has 4 specific aims: i) determine whether adolescent girls can safely offer oral HIV self-tests to their partners; ii) assess whether oral self-testing improves uptake of HIV testing among partners of adolescent girls; iii) document adverse events associated with offering oral self-testing to sexual partners of adolescent girls; and iv) qualitatively explore the experiences of adolescent girls when offering self-test kits to their partners.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: uptake of partner HIV testing
timeFrame: 3 months
Secondary outcomes:
measure: Introduce testing
timeFrame: 3 months
measure: Partner accept testing
timeFrame: 3 months
measure: Partner testing
timeFrame: 3 months
measure: Couples testing
timeFrame: 3 months
measure: Positive partner
timeFrame: 3 months
measure: linked to care
timeFrame: 3 months
measure: Intimate partner violence
timeFrame: 3 months
measure: Confirmatory testing for positive HIV self-test
timeFrame: 3 months
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Impact Research & Development Organization
Study officials:
affiliation: Impact Organization & Research Development
name: Kawango Agot, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Harsha Thirumurthy, PhD
role: PRINCIPAL_INVESTIGATOR
References: