Acceptability, Feasibility and Impact of Oral HIV Self-testing for Partner Testing Among Kenyan Adolescent Girls Aged 15-19 Years: A Randomized Controlled Trial
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

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.
    

Intervention name(s): Provision of multiple self-tests
Intervention type(s): Behavioral
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV self-testing; partner testing; couples testing; transactional sex; young women; adolescent girls; female sex workers