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

HIV-1-infection Clinical Trial

— PPS  

Official title:

Study of the Feasibility and Acceptability of an Adherence Promotion Package for Postpartum Women on Pre-exposure Prophylaxis (PrEP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04897737
• Other study ID #: K01TW011187-2
• Secondary ID: K01TW011187
• Status: Completed
• Phase: N/A
• Start date: November 5, 2020
• Est. completion date: May 18, 2021

Study information

• Verified date: March 2023
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Pregnant and breastfeeding women in South Africa are at very high risk of HIV acquisition and vertical HIV transmission during pregnancy, labour and breastfeeding. One-third to half of perinatal HIV transmission occurs in women who are seroconvert during the pregnancy and post-partum period. Effective use of pre-exposure prophylaxis (PrEP) could contribute to eliminating maternal HIV acquisition, and hence mother to child transmission (MTCT) of HIV. However, PrEP efficacy requires high levels of adherence, and adherence requires high levels of acceptability, yet there are few data on how best to promote adherence to PrEP in postpartum women.

We will conduct a study of the feasibility and acceptability of an adherence promotion package in n=100 postpartum women enrolled in an ongoing PrEP study (PrEP-PP; ongoing, R01MH116771) to evaluate the feasibility, acceptability and efficacy of a package of interventions to improve PrEP adherence in pregnancy and postpartum women. Specifically the package of interventions will include:

• Offer of HIV self-test in women and their partners with counseling on use

• Integrating urine based lateral flow assays in enhanced counseling using biofeedback on adherence levels to postpartum women on PrEP

The primary outcome is recent PrEP adherence at 1-month following the intervention. The secondary outcome is HIV testing uptake in participants' partners.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: May 18, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Currently enrolled in PrEP-PP study and on PrEP

2. 18+ years old

3. confirmed HIV-negative (confirmed with a 4th generation antigen HIV test)

4. confirmed to be postpartum (1-6 months postpartum)

5. confirmed to currently have a male partner

6. confirmed to have a cell phone that can read and respond to SMS/Whatsapp messages

Exclusion Criteria:

Failure to meet all of inclusion criteria

Related Conditions & MeSH terms

• HIV-1-infection

Intervention

Behavioral:
• 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.

Diagnostic Test:
• Orasure/UrSure test
See above

Locations

Country	Name	City	State
South Africa	Gugulethu Midwife Obstetric Unit	Cape Town

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	University of Cape Town

Country where clinical trial is conducted

South Africa, 

References & 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 Post — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events	Any adverse event occurring in the study including intimate partner violence, relationship issues, or conflict	During study monitoring
Primary	Recent PrEP Adherence	The primary study outcome is recent PrEP adherence according to urine tenofovir test by study arm.	1 month after intervention
Secondary	Participant Partners Who Tested for HIV	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.	1 month after intervention