Acceptability, Feasibility and Impact of Oral HIV Self-testing for Partner Testing Among Kenyan Adolescent Girls Aged 15-19 Years: A Randomized Controlled Trial

Sponsor

University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT04805112

Collaborator

Impact Research & Development Organization (Other), National Institute of Mental Health (NIMH) (NIH)

349

Enrollment

Location

Arms

Actual Duration (Months)

87.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Human Immunodeficiency Virus	Behavioral: Provision of multiple self-tests	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

349 participants

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.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

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

Actual Study Start Date :

Mar 2, 2021

Actual Primary Completion Date :

Apr 19, 2021

Actual Study Completion Date :

Jul 2, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Provision of multiple self-tests Participants randomized to the intervention group will be given 2-3 HIV oral self-tests to offer to their sexual partner(s). The participant will be instructed to encourage their partner to test himself alone [partner testing] or with the participant [couple testing]; the partner will also be given a card with information on testing and a list of facilities where he can go for confirmatory testing. All participants will be encouraged to call a study helpline/hotline in the event of any adverse events that they or their sexual partners experience or if they need further instructions or information	Behavioral: Provision of multiple self-tests 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
No Intervention: Referral vouchers for clinic testing Participants randomized to the control group will be given multiple referral coupons for HIV testing at pre-selected HIV testing services (HTS) sites. The participant will be instructed to give the coupon to their sexual partner(s) and encourage him to go for HIV testing at pre-selected HTS sites, either alone [partner testing] or together with the participant [couple testing]. The coupon will also have information on testing and a list of facilities where he can go for HTS. All participants will be encouraged to call a study helpline/hotline in the event of any adverse events that they or their sexual partners experience or if they need further instructions or information

Arm

Intervention/Treatment

Experimental: Provision of multiple self-tests

Participants randomized to the intervention group will be given 2-3 HIV oral self-tests to offer to their sexual partner(s). The participant will be instructed to encourage their partner to test himself alone [partner testing] or with the participant [couple testing]; the partner will also be given a card with information on testing and a list of facilities where he can go for confirmatory testing. All participants will be encouraged to call a study helpline/hotline in the event of any adverse events that they or their sexual partners experience or if they need further instructions or information

Behavioral: Provision of multiple self-tests

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

No Intervention: Referral vouchers for clinic testing

Participants randomized to the control group will be given multiple referral coupons for HIV testing at pre-selected HIV testing services (HTS) sites. The participant will be instructed to give the coupon to their sexual partner(s) and encourage him to go for HIV testing at pre-selected HTS sites, either alone [partner testing] or together with the participant [couple testing]. The coupon will also have information on testing and a list of facilities where he can go for HTS. All participants will be encouraged to call a study helpline/hotline in the event of any adverse events that they or their sexual partners experience or if they need further instructions or information

Outcome Measures

Primary Outcome Measures

uptake of partner HIV testing [3 months]
proportion of partners that complete HIV testing

Secondary Outcome Measures

Introduce testing [3 months]
proportion of participants who introduce testing to their partners
Partner accept testing [3 months]
proportion of partners who were offered HIVST or referral coupon and accepted
Partner testing [3 months]
proportion of participants who report their partner tested alone
Couples testing [3 months]
proportion of participants who report testing with their partner
Positive partner [3 months]
proportion of participants who report their partner test result was positive
linked to care [3 months]
Proportion of participants who report their partners was linked to care
Intimate partner violence [3 months]
proportion of participants in each study group who report intimate partner violence related to HIV testing
Confirmatory testing for positive HIV self-test [3 months]
proportion of participants in the intervention group who report their partner tested positive and went for confirmatory testing

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 19 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Impact Research & Development Organization	Kisumu		Kenya

Sponsors and Collaborators

University of Pennsylvania
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