Trial Outcomes & Findings for High-yield HIV Testing, Facilitated Linkage to Care, and Prevention for Female Youth in Kenya (NCT NCT02735642)

Last Updated: 2021-11-02

Results Overview

Our primary outcome for comparisons of recruitment and testing strategies was the number of newly diagnosed adolescent girls and young women living with HIV.

Recruitment status

COMPLETED

Study phase

Target enrollment

1198 participants

Primary outcome timeframe

Baseline

Results posted on

2021-11-02

Participant Flow

Participants were enrolled between May 2017 and April 2018 from three sites in Homa Bay County, Nyanza region, western Kenya. In fulfillment of Aim 1, we explored two recruitment approaches (homebased vs. mobile-event based) and three HIV testing options (oral self-test, staff-administered, or referral to health facility).

After participants completed HIV testing, only newly diagnosed participants living with HIV were enrolled into the SMART trial component of the study. This occurred from June 2017 to June 2018. Please note these are not additional participants, they are part of the N=1198 enrolled in the overall study.

Participant milestones

Participant milestones
Measure	Aim 1: Home-based Recruitment Strategy In fulfillment of Aim 1, we explored the home-based recruitment approach and three HIV testing options (oral self-test, staff-administered, or referral to health facility), to see which recruitment approach and testing modality would yield the highest number of newly diagnosed adolescent girls and young women living with HIV.	Aim 1: Mobile Event Based Recruitment Strategy In fulfillment of Aim 1, we explored the mobile event based recruitment approach and three HIV testing options (oral self-test, staff-administered, or referral to health facility), to see which recruitment approach and testing modality would yield the highest number of newly diagnosed adolescent girls and young women living with HIV.
Overall Study STARTED	1046	152
Overall Study COMPLETED	1046	152
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

High-yield HIV Testing, Facilitated Linkage to Care, and Prevention for Female Youth in Kenya

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Home-based Recruitment Strategy n=1046 Participants We explored two recruitment approaches (homebased vs. mobile-event based) and three HIV testing options (oral self-test, staff-administered, or referral to health facility).	Mobile Event Based Recruitment Strategy n=152 Participants We explored two recruitment approaches (homebased vs. mobile-event based) and three HIV testing options (oral self-test, staff-administered, or referral to health facility).	Total n=1198 Participants Total of all reporting groups
Age, Continuous	20 years n=5 Participants	19 years n=7 Participants	20 years n=5 Participants
Sex/Gender, Customized Adolescent girls and young women	1046 Participants n=5 Participants	152 Participants n=7 Participants	1198 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	1046 Participants n=5 Participants	152 Participants n=7 Participants	1198 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	1046 participants n=5 Participants	152 participants n=7 Participants	1198 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Our primary outcome for comparisons of recruitment and testing strategies was the number of newly diagnosed adolescent girls and young women living with HIV.

Outcome measures

Outcome measures
Measure	Home-based Recruitment Strategy n=1046 Participants In fulfillment of Aim 1, we explored the home-based recruitment approach and three HIV testing options (oral self-test, staff-administered, or referral to health facility), to see which recruitment approach and testing modality would yield the highest number of newly diagnosed adolescent girls and young women living with HIV.	Mobile Event Based Recruitment Strategy n=152 Participants In fulfillment of Aim 1, we explored the mobile event based recruitment approach and three HIV testing options (oral self-test, staff-administered, or referral to health facility), to see which recruitment approach and testing modality would yield the highest number of newly diagnosed adolescent girls and young women living with HIV.	SMART Randomization 2 - SMS Newly diagnosed adolescent girls and young women living with HIV that have not successfully linked to care after the first randomization were re-randomized to receive either an SMS message or economic incentive to link to care. In this second randomization, participants in this arm were randomized to receive an SMS message.	SMART Randomization 2 - Incentive Newly diagnosed adolescent girls and young women living with HIV that have not successfully linked to care after the first randomization were re-randomized to receive either an SMS message or economic incentive to link to care. In this second randomization, participants in this arm were randomized to receive an economic incentive.
Number of Newly Diagnosed Adolescent Girls and Young Women Living With HIV	23 Participants	9 Participants	—	—

SECONDARY outcome

Timeframe: Baseline to about 6 weeks

Population: Please note our SMART trial is underpowered because HIV prevalence was lower than expected. In the outcome measure data table below, we report the total numbers allocated to each intervention and the number of participants who successfully linked to care.

After completing HIV testing, newly diagnosed adolescent girls and young women (AGYW) (N=32) participated in an adaptive intervention pilot to figure out the best way to support those newly diagnosed with HIV with initial linkage to care. The SMART trial pilot consisted of two randomizations. In the first randomization, AGYW were assigned to either standard referral (counseling and a referral note) or standard referral plus SMS message; those not linked to care after the first randomization (within a 2-week period) were randomized a second time to receive either a SMS message or financial incentive to link to care.

Outcome measures

Outcome measures
Measure	Home-based Recruitment Strategy n=15 Participants In fulfillment of Aim 1, we explored the home-based recruitment approach and three HIV testing options (oral self-test, staff-administered, or referral to health facility), to see which recruitment approach and testing modality would yield the highest number of newly diagnosed adolescent girls and young women living with HIV.	Mobile Event Based Recruitment Strategy n=17 Participants In fulfillment of Aim 1, we explored the mobile event based recruitment approach and three HIV testing options (oral self-test, staff-administered, or referral to health facility), to see which recruitment approach and testing modality would yield the highest number of newly diagnosed adolescent girls and young women living with HIV.	SMART Randomization 2 - SMS n=1 Participants Newly diagnosed adolescent girls and young women living with HIV that have not successfully linked to care after the first randomization were re-randomized to receive either an SMS message or economic incentive to link to care. In this second randomization, participants in this arm were randomized to receive an SMS message.	SMART Randomization 2 - Incentive n=1 Participants Newly diagnosed adolescent girls and young women living with HIV that have not successfully linked to care after the first randomization were re-randomized to receive either an SMS message or economic incentive to link to care. In this second randomization, participants in this arm were randomized to receive an economic incentive.
SMART Trial Pilot to Link Newly Diagnosed Adolescent Girls and Young Women to HIV Care Services.	10 Participants	10 Participants	0 Participants	1 Participants

Adverse Events

Home-based Recruitment Strategy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Mobile Event Based Recruitment Strategy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Home-based Recruitment Strategy n=1046 participants at risk We explored two recruitment approaches (homebased vs. mobile-event based) and three HIV testing options (oral self-test, staff-administered, or referral to health facility).	Mobile Event Based Recruitment Strategy n=152 participants at risk We explored two recruitment approaches (homebased vs. mobile-event based) and three HIV testing options (oral self-test, staff-administered, or referral to health facility).
Social circumstances Social Harms	0.10% 1/1046 • Number of events 1 • Adverse events were collected from the date of first participant enrollment, until the date the last participant completed follow-up (about one year for those who participated in the longitudinal follow-up).	0.66% 1/152 • Number of events 1 • Adverse events were collected from the date of first participant enrollment, until the date the last participant completed follow-up (about one year for those who participated in the longitudinal follow-up).

Additional Information

Ann Kurth

Yale University School of Nursing

Phone: N/A

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place