Impact Research & Development Organization
Kisumu, Kenya
NCT Number: NCT04805112
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.
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Notify Me15 year–19 year
Female
Interventional
Not applicable
Kisumu, Kenya
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 3 months
proportion of partners that complete HIV testing
Time frame: 3 months
proportion of participants who introduce testing to their partners
Time frame: 3 months
proportion of partners who were offered HIVST or referral coupon and accepted
Time frame: 3 months
proportion of participants who report their partner tested alone
Time frame: 3 months
proportion of participants who report testing with their partner
Time frame: 3 months
proportion of participants who report their partner test result was positive
Time frame: 3 months
Proportion of participants who report their partners was linked to care
Time frame: 3 months
proportion of participants in each study group who report intimate partner violence related to HIV testing
Time frame: 3 months
proportion of participants in the intervention group who report their partner tested positive and went for confirmatory testing
University of Pennsylvania
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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