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

NCT04897737 | Completed Results DMC

• 2 other identifiers: K01TW011187-2K01TW011187
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

The postpartum PrEP study (PPS) seeks to evaluate how best to improve adherence to PrEP in postpartum women and to evaluate how acceptable it is to offer HIV self tests for the participant and partner, and provide enhanced adherence biofeedback following a urine test of recent PrEP use (measuring tenofovir). The primary outcome is recent PrEP adherence following the intervention. The secondary outcome is HIV testing uptake in participants' partners.

Conditions

HIV-1-infection

Keywords

PrEP; PMTCT; adherence; pregnant; postpartum; counseling; HIV self-testing

Outcome Measures

Primary Outcomes (1)

• Recent PrEP Adherence

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

  1 month after intervention

Secondary Outcomes (1)

• Participant Partners Who Tested for HIV

  1 month after intervention

Other Outcomes (1)

• Adverse Events

  During study monitoring

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: HIVST and enhanced adherence biofeedback; Diagnostic Test: Orasure/UrSure test

Control

NO INTERVENTION

Standard of care intervention including facility based HIV testing, referral for partner to attend facility for testing, and PrEP adherence counseling without biofeedback

Interventions

HIVST and enhanced adherence biofeedback BEHAVIORAL

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.

Also known as: urine tenofovir test, HIV self test

Intervention

Orasure/UrSure test DIAGNOSTIC_TEST

See above

Also known as: urine tenofovir test

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently enrolled in PrEP-PP study and on PrEP
• + years old
• confirmed HIV-negative (confirmed with a 4th generation antigen HIV test)
• confirmed to be postpartum (1-6 months postpartum)
• confirmed to currently have a male partner
• confirmed to have a cell phone that can read and respond to SMS/Whatsapp messages

Sponsors & Collaborators

• University of California, Los Angeles: lead
• University of Cape Town: collaborator

Study Sites (1)

Gugulethu Midwife Obstetric Unit

Cape Town, South Africa

Location

Related Publications (1)

• Joseph Davey DL, Dovel K, Mvududu R, Nyemba D, Mashele N, Bekker LG, Gorbach PM, Coates TJ, Myer L. Pre-exposure Prophylaxis Recent Adherence With Real-Time Adherence Feedback and Partner Human Immunodeficiency Virus Self-Testing: A Pilot Trial Among Postpartum Women. Open Forum Infect Dis. 2021 Dec 23;9(2):ofab609. doi: 10.1093/ofid/ofab609. eCollection 2022 Feb.

  PMID: 35097151 RESULT

Results Point of Contact

• Title: Dr. Dvora Joseph Davey, PI
• Organization: UCLA

dvoradavey@ucla.edu

310-701-1526

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 21, 2021
• Study Start: November 5, 2020
• Primary Completion: April 30, 2021
• Study Completion: May 18, 2021
• Last Updated: December 8, 2023
• Results First Posted: December 8, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 1 year
• Access Criteria: To contact PI for access to study data

Locations

ZA (1)