Trial Outcomes & Findings for Postpartum Pre-exposure Prophylaxis (PrEP) Study to Evaluate an Adherence Promotion Package for Postpartum Women on PrEP (NCT NCT04897737)

NCT ID: NCT04897737

Last Updated: 2023-12-08

Results Overview

The primary study outcome is recent PrEP adherence according to urine tenofovir test by study arm.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 106 participants
• Primary outcome timeframe: 1 month after intervention
• Results posted on: 2023-12-08

Participant Flow

Between August 2020 and April 2021, trained study staff recruited cisgender women from the PrEP-PP cohort for the pilot study. Eligibility criteria included having given birth to a live infant in the preceding 4-24 weeks, documented HIV-negative status in the study on the date of screening, initiating PrEP in the recently completed pregnancy, and reported having at least 1 sexual partner.

Participant milestones

Measure	Intervention HIV self-testing kits and counseling on use for participant and partner use + enhanced adherence counseling including urine tenofovir test to provide biofeedback in women using PrEP HIVST and enhanced adherence biofeedback: The intervention includes the provision of an OraQuick HIV self-test (HIVST) for the woman and one test for each of her reported sex partners, along with instructions on how to use and interpret the results. Women were asked to report back within one month if their partner was able to test via a SMS, WhatsApp or by bringing in the test to confirm that he had tested. Women then received adherence based feedback following the urine lateral flow assay (that measures recent tenofovir use in past 48 hours). Study counsellors requested that women provide a urine sample that was tested using the UrSure/Orasure test that provides feedback on the result in 2-3 minutes. Counselors provided counseling based on the results including how to improve daily adherence (for women without tenofovir present in their urine) and importance of condom use. Orasure/UrSure test: See above	Control Standard of care intervention including facility based HIV testing, referral for partner to attend facility for testing, and PrEP adherence counseling without biofeedback
Overall Study STARTED	53	53
Overall Study COMPLETED	53	53
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Postpartum Pre-exposure Prophylaxis (PrEP) Study to Evaluate an Adherence Promotion Package for Postpartum Women on PrEP

Baseline characteristics by cohort

Measure	Intervention n=53 Participants HIV self-testing kits and counseling on use for participant and partner use + enhanced adherence counseling including urine tenofovir test to provide biofeedback in women using PrEP HIVST and enhanced adherence biofeedback: The intervention includes the provision of an OraQuick HIV self-test (HIVST) for the woman and one test for each of her reported sex partners, along with instructions on how to use and interpret the results. Women were asked to report back within one month if their partner was able to test via a SMS, WhatsApp or by bringing in the test to confirm that he had tested. Women then received adherence based feedback following the urine lateral flow assay (that measures recent tenofovir use in past 48 hours). Study counsellors requested that women provide a urine sample that was tested using the UrSure/Orasure test that provides feedback on the result in 2-3 minutes. Counselors provided counseling based on the results including how to improve daily adherence (for women without tenofovir present in their urine) and importance of condom use. Orasure/UrSure test: See above	Control n=53 Participants Standard of care intervention including facility based HIV testing, referral for partner to attend facility for testing, and PrEP adherence counseling without biofeedback	Total n=106 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	53 Participants n=5 Participants	53 Participants n=7 Participants	106 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	26 Years n=5 Participants	26 Years n=7 Participants	26 Years n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants	53 Participants n=7 Participants	106 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	53 Participants n=5 Participants	53 Participants n=7 Participants	106 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 South Africa	53 Participants n=5 Participants	53 Participants n=7 Participants	106 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month after intervention

Population: Postpartum women on PrEP who had urine tenofovir present in urine (indicative of taking PrEP in last 2-3 days)

The primary study outcome is recent PrEP adherence according to urine tenofovir test by study arm.

Outcome measures

Measure	Intervention n=53 Participants HIV self-testing kits and counseling on use for participant and partner use + enhanced adherence counseling including urine tenofovir test to provide biofeedback in women using PrEP HIVST and enhanced adherence biofeedback: The intervention includes the provision of an OraQuick HIV self-test (HIVST) for the woman and one test for each of her reported sex partners, along with instructions on how to use and interpret the results. Women were asked to report back within one month if their partner was able to test via a SMS, WhatsApp or by bringing in the test to confirm that he had tested. Women then received adherence based feedback following the urine lateral flow assay (that measures recent tenofovir use in past 48 hours). Study counsellors requested that women provide a urine sample that was tested using the UrSure/Orasure test that provides feedback on the result in 2-3 minutes. Counselors provided counseling based on the results including how to improve daily adherence (for women without tenofovir present in their urine) and importance of condom use. Orasure/UrSure test: See above	Control n=53 Participants Standard of care intervention including facility based HIV testing, referral for partner to attend facility for testing, and PrEP adherence counseling without biofeedback
Recent PrEP Adherence	33 Participants	18 Participants

SECONDARY outcome

Timeframe: 1 month after intervention

Population: Postpartum women on PrEP

The secondary outcome was number of partners who tested for HIV (as reported by the female partner and confirmed with photo or used HIVST in intervention arm) by study arm.

Outcome measures

Measure	Intervention n=53 Participants HIV self-testing kits and counseling on use for participant and partner use + enhanced adherence counseling including urine tenofovir test to provide biofeedback in women using PrEP HIVST and enhanced adherence biofeedback: The intervention includes the provision of an OraQuick HIV self-test (HIVST) for the woman and one test for each of her reported sex partners, along with instructions on how to use and interpret the results. Women were asked to report back within one month if their partner was able to test via a SMS, WhatsApp or by bringing in the test to confirm that he had tested. Women then received adherence based feedback following the urine lateral flow assay (that measures recent tenofovir use in past 48 hours). Study counsellors requested that women provide a urine sample that was tested using the UrSure/Orasure test that provides feedback on the result in 2-3 minutes. Counselors provided counseling based on the results including how to improve daily adherence (for women without tenofovir present in their urine) and importance of condom use. Orasure/UrSure test: See above	Control n=53 Participants Standard of care intervention including facility based HIV testing, referral for partner to attend facility for testing, and PrEP adherence counseling without biofeedback
Participant Partners Who Tested for HIV	35 male partners	9 male partners

OTHER_PRE_SPECIFIED outcome

Timeframe: During study monitoring

Any adverse event occurring in the study including intimate partner violence, relationship issues, or conflict

Outcome measures

Outcome data not reported

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intervention n=53 participants at risk HIV self-testing kits and counseling on use for participant and partner use + enhanced adherence counseling including urine tenofovir test to provide biofeedback in women using PrEP HIVST and enhanced adherence biofeedback: The intervention includes the provision of an OraQuick HIV self-test (HIVST) for the woman and one test for each of her reported sex partners, along with instructions on how to use and interpret the results. Women were asked to report back within one month if their partner was able to test via a SMS, WhatsApp or by bringing in the test to confirm that he had tested. Women then received adherence based feedback following the urine lateral flow assay (that measures recent tenofovir use in past 48 hours). Study counsellors requested that women provide a urine sample that was tested using the UrSure/Orasure test that provides feedback on the result in 2-3 minutes. Counselors provided counseling based on the results including how to improve daily adherence (for women without tenofovir present in their urine) and importance of condom use. Orasure/UrSure test: See above	Control n=53 participants at risk Standard of care intervention including facility based HIV testing, referral for partner to attend facility for testing, and PrEP adherence counseling without biofeedback
Psychiatric disorders Intimate Partner Violence	1.9% 1/53 • Number of events 1 • 6 months Any adverse event including intimate partner violence (IPV) as defined by WHO	0.00% 0/53 • 6 months Any adverse event including intimate partner violence (IPV) as defined by WHO

Additional Information

Dr. Dvora Joseph Davey, PI

UCLA

Phone: 310-701-1526

Email: dvoradavey@ucla.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place