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

Human Immunodeficiency Virus Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04805112
• Other study ID #: 848410
• Status: Completed
• Phase: N/A
• Start date: March 2, 2021
• Est. completion date: July 2, 2021

Study information

• Verified date: July 2022
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 349
• Est. completion date: July 2, 2021
• Est. primary completion date: April 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus

Intervention

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

Locations

Country	Name	City	State
Kenya	Impact Research & Development Organization	Kisumu

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	Impact Research & Development Organization, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	uptake of partner HIV testing	proportion of partners that complete HIV testing	3 months
Secondary	Introduce testing	proportion of participants who introduce testing to their partners	3 months
Secondary	Partner accept testing	proportion of partners who were offered HIVST or referral coupon and accepted	3 months
Secondary	Partner testing	proportion of participants who report their partner tested alone	3 months
Secondary	Couples testing	proportion of participants who report testing with their partner	3 months
Secondary	Positive partner	proportion of participants who report their partner test result was positive	3 months
Secondary	linked to care	Proportion of participants who report their partners was linked to care	3 months
Secondary	Intimate partner violence	proportion of participants in each study group who report intimate partner violence related to HIV testing	3 months
Secondary	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	3 months