HivSCOPE-PPNCT05322629
Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women
A study testing PrEP adherence biofeedback in people with Hiv, run by University of California, Los Angeles at 1 site in South Africa.
Trial summary
To reach HIV-uninfected pregnant and breastfeeding women in South Africa, who are at very high risk of HIV, researchers will test a new and innovative package of interventions: 1) pre-exposure prophylaxis (PrEP), which is a daily antiretroviral pill that is both safe and effective for preventing HIV in pregnant and… Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hiv
- What is being tested?
- PrEP adherence biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 1 siteSouth Africa
- Study dates
- 7 Sep 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 16 years
- Plans to deliver at the study facility
- Documented HIV-negative according to two finger prick rapid tests (per national protocol for routine antenatal care) and confirmed with a 4th generation antigen HIV test
- Lives within 20 kilometers of the study facility
- Without psychiatric or medical contraindications to PrEP use
- >20 weeks pregnant
- Able and willing to consent to study participation.
Who cannot join
- Individuals not meeting the above criteria will be excluded.
- -
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Gugulethu Midwife Obstetric Unit
Cape Town, South Africa
About this study
Official title: Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women (SCOPE-PP) in South Africa
To reach HIV-uninfected pregnant and breastfeeding women in South Africa, who are at very high risk of HIV, researchers will test a new and innovative package of interventions: 1) pre-exposure prophylaxis (PrEP), which is a daily antiretroviral pill that is both safe and effective for preventing HIV in pregnant and breastfeeding mothers and 2)) enhanced adherence counseling combined with differentiated deliver of community PrEP delivery for women who have difficulties with regular PrEP use.
Our study will be among the first ever to evaluate the efficacy and cost-effectiveness of a PrEP intervention among pregnant and postpartum women and will play a key role in informing maternal PrEP interventions to eliminate HIV acquisition and transmission to partners and their infants.
Read the detailed description
HIV incidence doubles during pregnancy and postpartum period compared with non-pregnant women, underscoring the urgent need for prevention interventions tailored to high-risk pregnant and breastfeeding women. Incident maternal HIV infections lead to an estimated one-third of all infant HIV infections. South Africa expects over 90,000 infant HIV cases in the next decade; one-third of those can be prevented by eliminating maternal HIV acquisition. Pre-exposure prophylaxis (PrEP) in pregnancy and breastfeeding is safe and effective at preventing HIV. However, PrEP use remains low in pregnancy, and drop precipitously in the postpartum period.
Researchers will test a novel strategy to optimize PrEP in pregnant and postpartum women in South Africa. Our randomized control trial (RCT) is designed to address key barriers to maternal PrEP use and evaluate cost-effectiveness to inform national policy. This trial builds on our earlier work demonstrating the acceptability, feasibility, safety and potential efficacy of a package of interventions including PrEP, enhanced adherence counseling combined with community, differentiated delivery of PrEP for women who want to take PrEP but have difficulties with adherence.
Our team developed and piloted a novel intervention entitled, Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum women (SCOPE-PP) that addresses barriers to taking daily PrEP by reducing clinic visit frequency and empowering women to adhere to PrEP. Our team will evaluate SCOPE-PP in a pragmatic RCT of pregnant and postpartum women at risk of HIV acquisition. The study will enroll 750 pregnant women in antenatal care and follow them through 12-months' postpartum. Women in the intervention will be offered rapid PrEP collection with enhanced adherence counseling. Women with poor PrEP continuation and/or adherence who want to continue on PrEP will be offered a differentiated care model of PrEP delivery to de-link PrEP from clinical visits. The primary outcome is PrEP continuation and adherence in postpartum women, measured through drug levels of tenofovir diphosphate. The study aims to: 1) Evaluate the efficacy of the SCOPE-PP intervention on PrEP adherence in pregnant and postpartum women in a RCT; 2) Assess the acceptability and feasibility of integrating SCOPE-PP into ante- and postnatal care using a consolidated framework for implementation research (CFIR); and 3) Estimate the incremental cost effectiveness of SCOPE-PP vs. standard of care per HIV infection and disability-adjusted life-year averted. This research is critical to inform maternal PrEP interventions to eliminate HIV acquisition and transmission.
- Conditions
- Hiv
- Being tested
- PrEP adherence biofeedback, Standard of care counseling
- Keywords
- pregnant, postpartum, prevention of mother to child transmission, PrEP, pre-exposure prophylaxis, HIV prevention, breastfeeding
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEP adherence biofeedbackBehavioural
Services for women in the intervention arm includes bio-feedback adherence counseling based on urine lateral flow assays of tenofovir to measure adherence with rapid PrEP delivery .
Standard of care counselingBehavioural
Adherence counseling based on self report and following national guidelines
| Study group | Role | What they receive |
|---|---|---|
| Intervention (enhanced PrEP HIV biofeedback) | Experimental | Women in the intervention arm (n=375) will receive enhanced PrEP bio-feedback adherence counseling:
* Real-time novel immunoassay using urine that measures tenofovir and enhanced bio-feedback counseling. The novel urine assay shows tenofovir concentrations if PrEP is taken in the past 48 hours thereby enabling counselors to provide feedback on adherence levels, immediately.
* Enhanced counseling on recent adherence levels
* Rapid PrEP collection
In second randomization at 6m, women on PrEP with poor adherence or continuation, will be offered differentiated PrEP delivery in the community or in the clinic. The study will follow these participants for 15m to assess longer term PrEP continuation and adherence. Receives: Behavioral: PrEP adherence biofeedback |
| Standard of care | Active comparator | Women in the standard of care arm (n=375) will receive facility-based PrEP and monthly HIV testing in pregnancy and quarterly in postpartum. PrEP prescriptions and HIV testing will be provided according to the national PrEP guidelines. The women will be followed through 6m postpartum for the first randomization and through 15m with the standard of care for the second randomization. Receives: Behavioral: Standard of care counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to PrEP at 6 months after PrEP initiation
Number and proportion of participants who have objective levels of PrEP adherence after 6 months using urine tenofovir test (rapid test of tenofovir, a metabolite of PrEP; yes/no) and blood test (dried blood spots measuring tenofovir diphosphate; categorical measure) comparing the intervention to standard of care arms.
Measured: 6 months following study enrollment
Adherence to PrEP at 15 months after PrEP initiation
Number and proportion of participants who have objective levels of PrEP adherence after 15 months using urine tenofovir test (rapid test of tenofovir, a metabolite of PrEP; yes/no) and blood test (dried blood spots measuring tenofovir diphosphate; categorical measure) comparing the intervention to standard of care arms.
Measured: 15 months following study enrollment
Secondary outcomes (2)
HIV incidence (maternal and infant)
Number of new HIV infections in women and infants by study arm (diagnosed in study or found in participant medical records)
Measured: Any time during study follow up (through 15 months after enrollment)
Adverse events
Number of participants with adverse events as assessed by CTCAE v4.0, by study arm and treatment exposure
Measured: Any time during study follow up (through 15 months after enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start7 Sep 2022
- Primary completion30 May 2025
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HivStudies 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
- Model description
- In a randomized control trial of 750 women, the study team will evaluate: (1) PrEP continuation (missing \<1 PrEP collections) and (2) PrEP adherence per drug levels of TFV-DP at 6m follow up. Pregnant women who are on PrEP or initiate PrEP at baseline visit will be recruited and screened for eligibility during their routine antenatal services at gestational \>25 weeks using a set script for screening and a brief description of the study. Study staff will obtain written informed consent immediately following screening.
- Masking
- None (open label)
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), 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
- NCT05322629
- Sponsor's protocol ID
- IRB-21-1770
- Other IDs
- 3R01HD106862-04S1
- Acronym
- SCOPE-PP
- Status last verified
- May 2025
- First submitted
- 24 Mar 2022
- Last updated
- 3 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study team will share de-identified data upon request
Publications
Joseph Davey DL, Dovel K, Cleary S, Khadka N, Mashele N, Silliman M, Mvududu R, Nyemba DC, Coates TJ, Myer L. Stepped care to optimize pre-exposure prophylaxis (PrEP) effectiveness in pregnant and postpartum women (SCOPE-PP) in South Africa: a randomized control trial. BMC Public Health. 2022 Jul 7;22(1):1306. doi: 10.1186/s12889-022-13652-5.
PubMed 35799121
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women (SCOPE-PP) in South Africa
- ClinicalTrials.gov ID
- NCT05322629
- Acronym / sponsor ID
- SCOPE-PP / IRB-21-1770
- Conditions
- Hiv
- Keywords
- pregnant, postpartum, prevention of mother to child transmission, PrEP, pre-exposure prophylaxis, HIV prevention, breastfeeding
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Cape Town
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To reach HIV-uninfected pregnant and breastfeeding women in South Africa, who are at very high risk of HIV, researchers will test a new and innovative package of interventions: 1) pre-exposure prophylaxis (PrEP), which is a daily antiretroviral pill that is both safe and effective for preventing HIV in pregnant and breastfeeding mothers and 2)) enhanced adherence counseling combined with differentiated deliver of community PrEP delivery for women who have difficulties with regular PrEP use.
Our study will be among the first ever to evaluate the efficacy and cost-effectiveness of a PrEP intervention among pregnant and postpartum women and will play a key role in informing maternal PrEP interventions to eliminate HIV acquisition and transmission to partners and their infants.
Detailed description
HIV incidence doubles during pregnancy and postpartum period compared with non-pregnant women, underscoring the urgent need for prevention interventions tailored to high-risk pregnant and breastfeeding women. Incident maternal HIV infections lead to an estimated one-third of all infant HIV infections. South Africa expects over 90,000 infant HIV cases in the next decade; one-third of those can be prevented by eliminating maternal HIV acquisition. Pre-exposure prophylaxis (PrEP) in pregnancy and breastfeeding is safe and effective at preventing HIV. However, PrEP use remains low in pregnancy, and drop precipitously in the postpartum period.
Researchers will test a novel strategy to optimize PrEP in pregnant and postpartum women in South Africa. Our randomized control trial (RCT) is designed to address key barriers to maternal PrEP use and evaluate cost-effectiveness to inform national policy. This trial builds on our earlier work demonstrating the acceptability, feasibility, safety and potential efficacy of a package of interventions including PrEP, enhanced adherence counseling combined with community, differentiated delivery of PrEP for women who want to take PrEP but have difficulties with adherence.
Our team developed and piloted a novel intervention entitled, Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum women (SCOPE-PP) that addresses barriers to taking daily PrEP by reducing clinic visit frequency and empowering women to adhere to PrEP. Our team will evaluate SCOPE-PP in a pragmatic RCT of pregnant and postpartum women at risk of HIV acquisition. The study will enroll 750 pregnant women in antenatal care and follow them through 12-months' postpartum. Women in the intervention will be offered rapid PrEP collection with enhanced adherence counseling. Women with poor PrEP continuation and/or adherence who want to continue on PrEP will be offered a differentiated care model of PrEP delivery to de-link PrEP from clinical visits. The primary outcome is PrEP continuation and adherence in postpartum women, measured through drug levels of tenofovir diphosphate. The study aims to: 1) Evaluate the efficacy of the SCOPE-PP intervention on PrEP adherence in pregnant and postpartum women in a RCT; 2) Assess the acceptability and feasibility of integrating SCOPE-PP into ante- and postnatal care using a consolidated framework for implementation research (CFIR); and 3) Estimate the incremental cost effectiveness of SCOPE-PP vs. standard of care per HIV infection and disability-adjusted life-year averted. This research is critical to inform maternal PrEP interventions to eliminate HIV acquisition and transmission.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In a randomized control trial of 750 women, the study team will evaluate: (1) PrEP continuation (missing <1 PrEP collections) and (2) PrEP adherence per drug levels of TFV-DP at 6m follow up. Pregnant women who are on PrEP or initiate PrEP at baseline visit will be recruited and screened for eligibility during their routine antenatal services at gestational >25 weeks using a set script for screening and a brief description of the study. Study staff will obtain written informed consent immediately following screening.
| Arm | Type | Receives |
|---|---|---|
| Intervention (enhanced PrEP HIV biofeedback) | Experimental | Behavioral: PrEP adherence biofeedbackWomen in the intervention arm (n=375) will receive enhanced PrEP bio-feedback adherence counseling: * Real-time novel immunoassay using urine that measures tenofovir and enhanced bio-feedback counseling. The novel urine assay shows tenofovir concentrations if PrEP is taken in the past 48 hours thereby enabling counselors to provide feedback on adherence levels, immediately. * Enhanced counseling on recent adherence levels * Rapid PrEP collection In second randomization at 6m, women on PrEP with poor adherence or continuation, will be offered differentiated PrEP delivery in the community or in the clinic. The study will follow these participants for 15m to assess longer term PrEP continuation and adherence. |
| Standard of care | Active comparator | Behavioral: Standard of care counselingWomen in the standard of care arm (n=375) will receive facility-based PrEP and monthly HIV testing in pregnancy and quarterly in postpartum. PrEP prescriptions and HIV testing will be provided according to the national PrEP guidelines. The women will be followed through 6m postpartum for the first randomization and through 15m with the standard of care for the second randomization. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 16 years
- Plans to deliver at the study facility
- Documented HIV-negative according to two finger prick rapid tests (per national protocol for routine antenatal care) and confirmed with a 4th generation antigen HIV test
- Lives within 20 kilometers of the study facility
- Without psychiatric or medical contraindications to PrEP use
Key exclusion criteria (2 listed)
- Individuals not meeting the above criteria will be excluded.
- -
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 |
|---|---|---|
| PrEP adherence biofeedbackServices for women in the intervention arm includes bio-feedback adherence counseling based on urine lateral flow assays of tenofovir to measure adherence with rapid PrEP delivery . | Behavioural | Intervention (enhanced PrEP HIV biofeedback) |
| Standard of care counselingAdherence counseling based on self report and following national guidelines | Behavioural | Standard of care |
Primary outcome
Adherence to PrEP at 6 months after PrEP initiation
Time frame: 6 months following study enrollment
Number and proportion of participants who have objective levels of PrEP adherence after 6 months using urine tenofovir test (rapid test of tenofovir, a metabolite of PrEP; yes/no) and blood test (dried blood spots measuring tenofovir diphosphate; categorical measure) comparing the intervention to standard of care arms.
Adherence to PrEP at 15 months after PrEP initiation
Time frame: 15 months following study enrollment
Number and proportion of participants who have objective levels of PrEP adherence after 15 months using urine tenofovir test (rapid test of tenofovir, a metabolite of PrEP; yes/no) and blood test (dried blood spots measuring tenofovir diphosphate; categorical measure) comparing the intervention to standard of care arms.
2 secondary outcomes
HIV incidence (maternal and infant)
Time frame: Any time during study follow up (through 15 months after enrollment)
Adverse events
Time frame: Any time during study follow up (through 15 months after enrollment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
- Derived from this study: PubMed 35799121Joseph Davey DL, Dovel K, Cleary S, Khadka N, Mashele N, Silliman M, Mvududu R, Nyemba DC, Coates TJ, Myer L. Stepped care to optimize pre-exposure prophylaxis (PrEP) effectiveness in pregnant and postpartum women (SCOPE-PP) in South Africa: a randomized control trial. BMC Public Health. 2022 Jul 7;22(1):1306. doi: 10.1186/s12889-022-13652-5.
- Individual participant dataSharing planned: Yes. The study team will share de-identified data upon request
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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 PrEP adherence biofeedback in people with Hiv, 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 7 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Adherence to PrEP at 6 months after PrEP initiation (time frame: 6 months following study enrollment). The study lists 2 primary outcomes in all. 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 NCT05322629, 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 3 Nov 2025.