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

NCT ID: NCT04897737

Last Updated: 2023-12-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-05

Study Completion Date

2021-05-18

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV-1-infection

Keywords

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PrEP PMTCT adherence pregnant postpartum counseling HIV self-testing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

HIVST and enhanced adherence biofeedback

Intervention Type 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.

Orasure/UrSure test

Intervention Type DIAGNOSTIC_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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Orasure/UrSure test

See above

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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urine tenofovir test HIV self test urine tenofovir test

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Cape Town

OTHER

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Dvora Joseph Davey, PhD, MPH

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gugulethu Midwife Obstetric Unit

Cape Town, , South Africa

Site Status

Countries

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South Africa

References

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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.

Reference Type RESULT
PMID: 35097151 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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K01TW011187

Identifier Type: NIH

Identifier Source: secondary_id

View Link

K01TW011187-2

Identifier Type: -

Identifier Source: org_study_id