Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Human Immunodeficiency Virus
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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.Masking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 15 years and 19 years
Gender
Only males

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 ...

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.

Tracking Information

NCT #
NCT04805112
Collaborators
  • Impact Research & Development Organization
  • National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Kawango Agot, PhD Impact Organization & Research Development Principal Investigator: Harsha Thirumurthy, PhD University of Pennsylvania