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

Primary Purpose

Human Immunodeficiency Virus

Status
Completed
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Provision of multiple self-tests
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Immunodeficiency Virus focused on measuring HIV self-testing, partner testing, couples testing, transactional sex, young women, adolescent girls, female sex workers

Eligibility Criteria

15 Years - 19 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Impact Research & Development Organization

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Provision of multiple self-tests

Referral vouchers for clinic testing

Arm Description

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

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

Outcomes

Primary Outcome Measures

uptake of partner HIV testing
proportion of partners that complete HIV testing

Secondary Outcome Measures

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

Full Information

First Posted
March 16, 2021
Last Updated
July 19, 2022
Sponsor
University of Pennsylvania
Collaborators
Impact Research & Development Organization, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04805112
Brief 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
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 2, 2021 (Actual)
Primary Completion Date
April 19, 2021 (Actual)
Study Completion Date
July 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Impact Research & Development Organization, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus
Keywords
HIV self-testing, partner testing, couples testing, transactional sex, young women, adolescent girls, female sex workers

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
349 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Provision of multiple self-tests
Arm Type
Experimental
Arm Description
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
Arm Title
Referral vouchers for clinic testing
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Provision of multiple self-tests
Intervention Description
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
Primary Outcome Measure Information:
Title
uptake of partner HIV testing
Description
proportion of partners that complete HIV testing
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Introduce testing
Description
proportion of participants who introduce testing to their partners
Time Frame
3 months
Title
Partner accept testing
Description
proportion of partners who were offered HIVST or referral coupon and accepted
Time Frame
3 months
Title
Partner testing
Description
proportion of participants who report their partner tested alone
Time Frame
3 months
Title
Couples testing
Description
proportion of participants who report testing with their partner
Time Frame
3 months
Title
Positive partner
Description
proportion of participants who report their partner test result was positive
Time Frame
3 months
Title
linked to care
Description
Proportion of participants who report their partners was linked to care
Time Frame
3 months
Title
Intimate partner violence
Description
proportion of participants in each study group who report intimate partner violence related to HIV testing
Time Frame
3 months
Title
Confirmatory testing for positive HIV self-test
Description
proportion of participants in the intervention group who report their partner tested positive and went for confirmatory testing
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kawango Agot, PhD
Organizational Affiliation
Impact Organization & Research Development
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Harsha Thirumurthy, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Impact Research & Development Organization
City
Kisumu
Country
Kenya

12. IPD Sharing Statement

Plan to Share IPD
No

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

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