HIV-1-infectionPPSNCT04897737
Postpartum Pre-exposure Prophylaxis (PrEP) Study to Evaluate an Adherence Promotion Package for Postpartum Women on PrEP
A study testing HIVST and enhanced adherence biofeedback and Orasure/UrSure test in people with HIV-1-infection, run by University of California, Los Angeles at 1 site in South Africa.
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- HIVST and enhanced adherence biofeedback and Orasure/UrSure test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteSouth Africa
- Study dates
- 5 Nov 2020to 18 May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Currently enrolled in PrEP-PP study and on PrEP
- 18+ 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
Who cannot join
- Failure to meet all of inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Feasibility and Acceptability of an Adherence Promotion Package for Postpartum Women on Pre-exposure Prophylaxis (PrEP)
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.
Read the detailed 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.
- Conditions
- HIV-1-infection
- Being tested
- HIVST and enhanced adherence biofeedback, Orasure/UrSure test
- Keywords
- PrEP, PMTCT, adherence, pregnant, postpartum, counseling, HIV self-testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIVST and enhanced adherence biofeedbackBehavioural
Also called urine tenofovir test, HIV self test
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 testDiagnostic test
Also called urine tenofovir test
See above
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recent PrEP Adherence
The primary study outcome is recent PrEP adherence according to urine tenofovir test by study arm.
Measured: 1 month after intervention
Secondary outcomes (1)
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.
Measured: 1 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start5 Nov 2020
- Primary completion30 Apr 2021
- Study completion18 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cape Town
- Responsible party
- Principal investigator, Dvora Joseph Davey, PhD, MPH, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897737
- Sponsor's protocol ID
- K01TW011187-2
- Other IDs
- K01TW011187
- Acronym
- PPS
- Status last verified
- Mar 2023
- First submitted
- 18 May 2021
- Last updated
- 8 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers can contact PI to decide on sharing IPD for further analyses.
Publications
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.
PubMed 35097151
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Feasibility and Acceptability of an Adherence Promotion Package for Postpartum Women on Pre-exposure Prophylaxis (PrEP)
- ClinicalTrials.gov ID
- NCT04897737
- Acronym / sponsor ID
- PPS / K01TW011187-2
- Conditions
- HIV-1-infection
- Keywords
- PrEP, PMTCT, adherence, pregnant, postpartum, counseling, HIV self-testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- University of Cape Town
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 18 May 2021 (actual)
- First posted
- 21 May 2021 (actual)
- Results
- Posted 8 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: HIVST and enhanced adherence biofeedback, Diagnostic Test: Orasure/UrSure testHIV 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 |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Currently enrolled in PrEP-PP study and on PrEP
- 18+ 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
Key exclusion criteria (1 listed)
- Failure to meet all of inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIVST and enhanced adherence biofeedbackAlso: urine tenofovir test, HIV self testThe 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. | Behavioural | Intervention |
| Orasure/UrSure testAlso: urine tenofovir testSee above | Diagnostic test | Intervention |
Primary outcome
Recent PrEP Adherence
Time frame: 1 month after intervention
The primary study outcome is recent PrEP adherence according to urine tenofovir test by study arm.
1 secondary outcome
Participant Partners Who Tested for HIV
Time frame: 1 month after intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35097151Joseph 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.
- Individual participant dataSharing planned: Yes. Researchers can contact PI to decide on sharing IPD for further analyses.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIVST and enhanced adherence biofeedback and Orasure/UrSure test in people with HIV-1-infection, run by University of California, Los Angeles at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recent PrEP Adherence (time frame: 1 month after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04897737, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.