Trial Outcomes & Findings for Secondary Distribution of HIV Self-tests: an Innovative Strategy for Promoting Partner Testing and Reducing HIV Risk (NCT NCT03135067)

Results Overview

HIV incidence over an average follow-up period of 18 months, and up to 24 months, per 100 person years

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

2102 participants

Primary outcome timeframe

up to 24 months

Results posted on

2022-12-16

Participant Flow

Unit of analysis: Community

Participant milestones

Participant milestones
Measure	Provision of Multiple Self-tests Participants in intervention clusters will be given multiple HIV self-test kits, testing instructions, and advice to use their discretion when offering self-tests to selected sexual partners. Participants will be encouraged to offer self-tests primarily to current and potential partners with whom unprotected sex is likely. All participants will be encouraged to use condoms with sexual partners. Participants will also be advised to assess the risk of intimate partner violence (IPV) as a result of offering self-tests to partners. Participants will have opportunities to obtain additional HIV self-test kits on a monthly basis. Provision of multiple self-tests: Participants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for offering to selected sexual partners. The self-test kits will be given to participants on a monthly basis as needed. The intervention is designed to facilitate partner and couples testing, with resulting reduction in risky sexual behavior and HIV incidence among participants.	Referral Vouchers for VCT Participants will be given a multiple referral vouchers for HIV testing to distribute to their sexual partners. All participants will be encouraged to use condoms with sexual partners. These referral vouchers will encourage the partners to seek HIV counseling \& testing services in local clinics. Participants will also be advised to assess the risk of intimate partner violence (IPV) as a result of offering referral vouchers to partners. Participants will have opportunities to obtain additional referral vouchers on a monthly basis.
Overall Study STARTED	1063 33	1039 33
Overall Study COMPLETED	1019 33	991 33
Overall Study NOT COMPLETED	44 0	48 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Secondary Distribution of HIV Self-tests: an Innovative Strategy for Promoting Partner Testing and Reducing HIV Risk

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Provision of Multiple Self-tests n=1054 Participants Participants in intervention clusters will be given multiple HIV self-test kits, testing instructions, and advice to use their discretion when offering self-tests to selected sexual partners. Participants will be encouraged to offer self-tests primarily to current and potential partners with whom unprotected sex is likely. All participants will be encouraged to use condoms with sexual partners. Participants will also be advised to assess the risk of intimate partner violence (IPV) as a result of offering self-tests to partners. Participants will have opportunities to obtain additional HIV self-test kits on a monthly basis. Provision of multiple self-tests: Participants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for offering to selected sexual partners. The self-test kits will be given to participants on a monthly basis as needed. The intervention is designed to facilitate partner and couples testing, with resulting reduction in risky sexual behavior and HIV incidence among participants.	Referral Vouchers for VCT n=1032 Participants Participants will be given a multiple referral vouchers for HIV testing to distribute to their sexual partners. All participants will be encouraged to use condoms with sexual partners. These referral vouchers will encourage the partners to seek HIV counseling \& testing services in local clinics. Participants will also be advised to assess the risk of intimate partner violence (IPV) as a result of offering referral vouchers to partners. Participants will have opportunities to obtain additional referral vouchers on a monthly basis.	Total n=2086 Participants Total of all reporting groups
Age, Continuous	26 years n=5 Participants	25 years n=7 Participants	25 years n=5 Participants
Sex: Female, Male Female	1054 Participants n=5 Participants	1032 Participants n=7 Participants	2086 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1054 Participants n=5 Participants	1032 Participants n=7 Participants	2086 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Kenya	1054 Participants n=5 Participants	1032 Participants n=7 Participants	2086 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 24 months

HIV incidence over an average follow-up period of 18 months, and up to 24 months, per 100 person years

Outcome measures

Outcome measures
Measure	Provision of Multiple Self-tests n=1019 Participants Participants in intervention clusters will be given multiple HIV self-test kits, testing instructions, and advice to use their discretion when offering self-tests to selected sexual partners. Participants will be encouraged to offer self-tests primarily to current and potential partners with whom unprotected sex is likely. All participants will be encouraged to use condoms with sexual partners. Participants will also be advised to assess the risk of intimate partner violence (IPV) as a result of offering self-tests to partners. Participants will have opportunities to obtain additional HIV self-test kits on a monthly basis. Provision of multiple self-tests: Participants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for offering to selected sexual partners. The self-test kits will be given to participants on a monthly basis as needed. The intervention is designed to facilitate partner and couples testing, with resulting reduction in risky sexual behavior and HIV incidence among participants.	Referral Vouchers for VCT n=991 Participants Participants will be given a multiple referral vouchers for HIV testing to distribute to their sexual partners. All participants will be encouraged to use condoms with sexual partners. These referral vouchers will encourage the partners to seek HIV counseling \& testing services in local clinics. Participants will also be advised to assess the risk of intimate partner violence (IPV) as a result of offering referral vouchers to partners. Participants will have opportunities to obtain additional referral vouchers on a monthly basis.
HIV Incidence Per 100 Person Years	1.18 cases per 100 person years	.98 cases per 100 person years

SECONDARY outcome

Timeframe: up to 24 months

Average number of sexual partners per participant that the participant reported as HIV positive over the course of the study (Total reported positive sexual partners divided by number of participants who completed at least one 6-month follow-up survey); the intent of this measure is to see if participants given HIV self-tests are more likely to identify HIV positive sexual partners.

Outcome measures

Outcome measures
Measure	Provision of Multiple Self-tests n=1017 Participants Participants in intervention clusters will be given multiple HIV self-test kits, testing instructions, and advice to use their discretion when offering self-tests to selected sexual partners. Participants will be encouraged to offer self-tests primarily to current and potential partners with whom unprotected sex is likely. All participants will be encouraged to use condoms with sexual partners. Participants will also be advised to assess the risk of intimate partner violence (IPV) as a result of offering self-tests to partners. Participants will have opportunities to obtain additional HIV self-test kits on a monthly basis. Provision of multiple self-tests: Participants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for offering to selected sexual partners. The self-test kits will be given to participants on a monthly basis as needed. The intervention is designed to facilitate partner and couples testing, with resulting reduction in risky sexual behavior and HIV incidence among participants.	Referral Vouchers for VCT n=985 Participants Participants will be given a multiple referral vouchers for HIV testing to distribute to their sexual partners. All participants will be encouraged to use condoms with sexual partners. These referral vouchers will encourage the partners to seek HIV counseling \& testing services in local clinics. Participants will also be advised to assess the risk of intimate partner violence (IPV) as a result of offering referral vouchers to partners. Participants will have opportunities to obtain additional referral vouchers on a monthly basis.
Identification of HIV-positive Male Partners	.26 partners per participants Standard Deviation 0.71	.13 partners per participants Standard Deviation 0.48

SECONDARY outcome

Timeframe: Data was measured longitudinally up to 24 months for some subjects; all participants were measured through 18 months. Measures reported are from 18 month follow-up for behavior occurring in the past 6 months.