HIV-1-infection
Conditions
Keywords
PrEP, PMTCT, adherence, pregnant, postpartum, counseling, HIV self-testing
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.
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.
Interventions
BEHAVIORALHIVST 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_TESTOrasure/UrSure test
See above
Sponsors
University of Cape Town
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recent PrEP Adherence | 1 month after intervention | The primary study outcome is recent PrEP adherence according to urine tenofovir test by study arm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Partners Who Tested for HIV | 1 month after intervention | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | During study monitoring | Any adverse event occurring in the study including intimate partner violence, relationship issues, or conflict |
Countries
South Africa
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 53 |
| Control Standard of care intervention including facility based HIV testing, referral for partner to attend facility for testing, and PrEP adherence counseling without biofeedback | 53 |
| Total | 106 |
Baseline characteristics
| Characteristic | Control | Total | Intervention |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 53 Participants | 106 Participants | 53 Participants |
| Age, Continuous | 26 Years | 26 Years | 26 Years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 53 Participants | 106 Participants | 53 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment South Africa | 53 Participants | 106 Participants | 53 Participants |
| Sex: Female, Male Female | 53 Participants | 106 Participants | 53 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 53 |
| other Total, other adverse events | 1 / 53 | 0 / 53 |
| serious Total, serious adverse events | 0 / 53 | 0 / 53 |
Outcome results
Primary
Recent PrEP Adherence
The primary study outcome is recent PrEP adherence according to urine tenofovir test by study arm.
Time frame: 1 month after intervention
Population: Postpartum women on PrEP who had urine tenofovir present in urine (indicative of taking PrEP in last 2-3 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Recent PrEP Adherence | 33 Participants |
| Control | Recent PrEP Adherence | 18 Participants |
Comparison: All analyses were by intention-to-treat. In the case of missing outcomes for participants who did not return for the follow-up visit, we assigned outcome values of the following: poor PrEP adherence (TFV undetected) and partner not tested for HIV. We constructed univariate Poisson regression models with robust standard errors to examine the predictors of outcomes of interests. Model results are presented as crude risk ratios (RRs) and risk differences (RDs) with 95% CIs.p-value: <0.00195% CI: [1.19, 2.82]Mixed Models Analysis
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.
Time frame: 1 month after intervention
Population: Postpartum women on PrEP
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Participant Partners Who Tested for HIV | 35 male partners |
| Control | Participant Partners Who Tested for HIV | 9 male partners |
Comparison: All analyses were by intention-to-treat. In the case of missing outcomes for participants who did not return for the follow-up visit, we assigned outcome values of the following: poor PrEP adherence (TFV undetected) and partner not tested for HIV. We constructed univariate Poisson regression models with robust standard errors to examine the predictors of outcomes of interests. Model results are presented as crude risk ratios (RRs) and 95% CIs.p-value: <0.00195% CI: [2.08, 7.27]Regression, Linear
Other Pre-specified
Adverse Events
Any adverse event occurring in the study including intimate partner violence, relationship issues, or conflict
Time frame: During study monitoring