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| ID | Type | Description | Link |
|---|---|---|---|
| K01TW011187 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| University of Cape Town | OTHER |
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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.
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:
The primary outcome is recent PrEP adherence at 1-month following the intervention. The secondary outcome is HIV testing uptake in participants' partners.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recent PrEP Adherence | The primary study outcome is recent PrEP adherence according to urine tenofovir test by study arm. | 1 month after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Any adverse event occurring in the study including intimate partner violence, relationship issues, or conflict | During study monitoring |
Inclusion Criteria:
Exclusion Criteria:
Failure to meet all of inclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gugulethu Midwife Obstetric Unit | Cape Town | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35097151 | Result | 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. |
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Researchers can contact PI to decide on sharing IPD for further analyses.
1 year
To contact PI for access to study data
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 7, 2020 |
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| Orasure/UrSure test | Diagnostic Test | See above |
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| FG001 | Control | Standard of care intervention including facility based HIV testing, referral for partner to attend facility for testing, and PrEP adherence counseling without biofeedback |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Control | Standard of care intervention including facility based HIV testing, referral for partner to attend facility for testing, and PrEP adherence counseling without biofeedback |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Inter-Quartile Range | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Recent PrEP Adherence | The primary study outcome is recent PrEP adherence according to urine tenofovir test by study arm. | Postpartum women on PrEP who had urine tenofovir present in urine (indicative of taking PrEP in last 2-3 days) | Posted | Count of Participants | Participants | 1 month after intervention |
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| 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. | Postpartum women on PrEP | Posted | Number | male partners | 1 month after intervention |
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| Other Pre-specified | Adverse Events | Any adverse event occurring in the study including intimate partner violence, relationship issues, or conflict | Not Posted | During study monitoring | Participants |
6 months
Any adverse event including intimate partner violence (IPV) as defined by WHO
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 53 | 0 | 53 | 1 | 53 |
| EG001 | Control | Standard of care intervention including facility based HIV testing, referral for partner to attend facility for testing, and PrEP adherence counseling without biofeedback | 0 | 53 | 0 | 53 | 0 | 53 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intimate Partner Violence | Psychiatric disorders | Non-systematic Assessment | Partner yelling and conflict after testing |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dvora Joseph Davey, PI | UCLA | 310-701-1526 | dvoradavey@ucla.edu |
| Mar 7, 2023 |
| Prot_SAP_000.pdf |
| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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Standard of care intervention including facility based HIV testing, referral for partner to attend facility for testing, and PrEP adherence counseling without biofeedback
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