HivPhase 4PrEP-PPNCT03826199

Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town (Formative Study)

A Phase 4 study testing TDF-FTC and Counselling on PrEP in antenatal and postnatal care in people with Hiv, run by University of California, Los Angeles at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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?: TDF-FTC and Counselling on PrEP in antenatal and postnatal care
Type of treatment: Lifestyle or therapy programme
How many people: 200 participants
Where: 1 siteSouth Africa
Study dates: 23 Aug 2019to 30 Sep 2023
Phase: Phase 4
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 16 years and older
Women only
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Documented HIV-negative according to two fingerpick rapid tests (per routine antenatal care protocol in this setting), confirmed with a 4th generation antigen HIV test at study enrollment
No previous exposure triple-drug antiretroviral therapy
Age 18 years or older
Lives within 20 kilometers of a clinic
Without psychiatric or medical contraindications to PrEP use
Able to provide informed consent for research

Who cannot join

Failure to meet any of the inclusion criteria

Trial locations and contacts

1 site in 1 country.

South Africa1 site

Gugulethu Midwife Obstetric Unit
Cape Town

Other trials in South Africa

About this study

Official title: Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town, South Africa (Formative Study)

The overarching goal of this proposal is to evaluate the feasibility and acceptability of integrating PrEP into antenatal and postnatal care, to describe the cascade in women initiating PrEP in this setting, and to evaluate the reasons for attrition along the PrEP cascade in a cohort of pregnant and breastfeeding women. The specific aims are to: (1) Evaluate the feasibility and acceptability of integrating PrEP into antenatal and postnatal/well-baby services; (2) Describe the PrEP cascade of initiation, retention, and adherence in a cohort of 220 HIV-uninfected pregnant and breastfeeding women, (3) Evaluate attrition and associated factors across the PrEP cascade.

Conditions: Hiv
Being tested: TDF-FTC, Counselling on PrEP in antenatal and postnatal care
Keywords: pre-exposure prophylaxis, PrEP, pregnancy, prevention of mother to child transmission, PMTCT
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TDF-FTCDrug
Also called PrEP, Truvada
We will investigate the feasibility and acceptability of integrating PrEP into antenatal and postnatal/well-baby services. Upon enrollment in the cascade, all women will be offered PrEP counseling and information, and patients will be followed regardless of their choice to initiate PrEP or not. Participants who initiate PrEP will receive TDF-FTC during the study. At each study visit (every 3-months), women will receive counseling on PrEP adherence or on the risks and benefits of PrEP for women not yet initiated. We will evaluate PrEP initiation and adherence in pregnant and breastfeeding women (N=220) from first antenatal care visit through 12 months post-partum.
Counselling on PrEP in antenatal and postnatal careBehavioural
Information about PrEP will be integrated into regular group education in ANC by existing health care providers during discussion about HIV testing and treatment. During every study visit, PrEP counseling (including adherence counseling for women already on PrEP) will be provided. For women not on PrEP, counselling will be provided on PrEP and HIV prevention.

What is being measured

The primary outcome is the main question the study is designed to answer.

PrEP Retention
number of women on PrEP who return for study visits (do not miss more than 1 visit) / total number of women in active cohort who are prescribed PrEP
Measured: 18 months
PrEP Adherence
number of women taking PrEP who have >80 percent levels at >40ng/mL tenofovir diphosphate (indicating dosing in past 24 hours) / total woman-time on PrEP in active cohort = PrEP adherence rate (objective)
Measured: 3 months

Secondary outcomes (3)

PrEP Initiation
number of women who initiate PrEP over time/ total number of women in active cohort
Measured: 18 months
PrEP Adherence (Peri-sexual)
number of women taking PrEP who have >80 percent levels at >40ng/mL tenofovir diphosphate (indicating dosing in past 24 hours) / total woman-time when women report condomless sex in past week= PrEP adherence rate (peri-sexual)
Measured: 3 months
PrEP Adherence (Subjective, Self-reported)
number of women taking PrEP, who self-report taking their medication daily (and pill count to confirm this) during periods of sexual risk over time / total woman time on PrEP in active cohort = PrEP adherence rate (subjective)
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Aug 201930 Sep 2023

First posted1 Feb 2019
Study start23 Aug 2019
Primary completion1 Dec 2021
Study completion30 Sep 2023

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 (6)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 4
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Model description: Open label cohort study
Masking: None (open label)
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03826199
Sponsor's protocol ID: K01TW011187
Acronym: PrEP-PP
Status last verified: Nov 2023
First submitted: 25 Jan 2019
Last updated: 1 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Joseph Davey D, Myer L, Coates T. PrEP implementation in pregnant and post-partum women. Lancet HIV. 2020 Jan;7(1):e5-e6. doi: 10.1016/S2352-3018(19)30371-6. Epub 2019 Dec 5. No abstract available.
PubMed 31813838
Khadka N, Gorbach PM, Nyemba DC, Mvududu R, Mashele N, Javanbakht M, Nianogo RA, Aldrovandi GM, Bekker LG, Coates TJ, Myer L, Joseph Davey DL. Evaluating the use of oral pre-exposure prophylaxis among pregnant and postpartum adolescent girls and young women in Cape Town, South Africa. Front Reprod Health. 2023 Sep 19;5:1224474. doi: 10.3389/frph.2023.1224474. eCollection 2023.
PubMed 37795521
Joseph Davey DL, Knight L, Markt-Maloney J, Tsawe N, Gomba Y, Mashele N, Dovel K, Gorbach P, Bekker LG, Coates TJ, Myer L. "I had Made the Decision, and No One was Going to Stop Me" -Facilitators of PrEP Adherence During Pregnancy and Postpartum in Cape Town, South Africa. AIDS Behav. 2021 Dec;25(12):3978-3986. doi: 10.1007/s10461-021-03320-x. Epub 2021 Jun 3.
PubMed 34085132
Joseph Davey DL, Mvududu R, Mashele N, Lesosky M, Khadka N, Bekker LG, Gorbach P, Coates TJ, Myer L. Early pre-exposure prophylaxis (PrEP) initiation and continuation among pregnant and postpartum women in antenatal care in Cape Town, South Africa. J Int AIDS Soc. 2022 Feb;25(2):e25866. doi: 10.1002/jia2.25866.
PubMed 35138678
Moran A, Mashele N, Mvududu R, Gorbach P, Bekker LG, Coates TJ, Myer L, Joseph Davey D. Maternal PrEP Use in HIV-Uninfected Pregnant Women in South Africa: Role of Stigma in PrEP Initiation, Retention and Adherence. AIDS Behav. 2022 Jan;26(1):205-217. doi: 10.1007/s10461-021-03374-x. Epub 2021 Jul 21.
PubMed 34287756
Haribhai S, Khadka N, Mvududu R, Mashele N, Bekker LG, Gorbach P, Coates TJ, Myer L, Joseph Davey DL. Psychosocial determinants of pre-exposure prophylaxis use among pregnant adolescent girls and young women in Cape Town, South Africa: A qualitative study. Int J STD AIDS. 2023 Jul;34(8):548-556. doi: 10.1177/09564624231152776. Epub 2023 Mar 22.
PubMed 36947792

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Hiv trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town, South Africa (Formative Study)
ClinicalTrials.gov ID: NCT03826199
Acronym / sponsor ID: PrEP-PP / K01TW011187
Conditions: Hiv
Keywords: pre-exposure prophylaxis, PrEP, pregnancy, prevention of mother to child transmission, PMTCT
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: University of California, Los AngelesUniversity, hospital or other
Collaborators: University of Cape Town, Desmond Tutu HIV Foundation
Study start: 23 Aug 2019 (actual)
Primary completion: 1 Dec 2021 (actual)
Study completion: 30 Sep 2023 (actual)
First posted: 1 Feb 2019 (actual)
Results: Posted 16 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Model description: Open label cohort study

Who may qualify

Ages: 16 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

Documented HIV-negative according to two fingerpick rapid tests (per routine antenatal care protocol in this setting), confirmed with a 4th generation antigen HIV test at study enrollment
No previous exposure triple-drug antiretroviral therapy
Age 18 years or older
Lives within 20 kilometers of a clinic
Without psychiatric or medical contraindications to PrEP use

Key exclusion criteria (1 listed)

Failure to meet any of the 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
TDF-FTCAlso: PrEP, TruvadaWe will investigate the feasibility and acceptability of integrating PrEP into antenatal and postnatal/well-baby services. Upon enrollment in the cascade, all women will be offered PrEP counseling and information, and patients will be followed regardless of their choice to initiate PrEP or not. Participants who initiate PrEP will receive TDF-FTC during the study. At each study visit (every 3-months), women will receive counseling on PrEP adherence or on the risks and benefits of PrEP for women not yet initiated. We will evaluate PrEP initiation and adherence in pregnant and breastfeeding women (N=220) from first antenatal care visit through 12 months post-partum.	Drug	–
Counselling on PrEP in antenatal and postnatal careInformation about PrEP will be integrated into regular group education in ANC by existing health care providers during discussion about HIV testing and treatment. During every study visit, PrEP counseling (including adherence counseling for women already on PrEP) will be provided. For women not on PrEP, counselling will be provided on PrEP and HIV prevention.	Behavioural	–

Primary outcome

PrEP Retention
Time frame: 18 months
number of women on PrEP who return for study visits (do not miss more than 1 visit) / total number of women in active cohort who are prescribed PrEP
PrEP Adherence
Time frame: 3 months
number of women taking PrEP who have >80 percent levels at >40ng/mL tenofovir diphosphate (indicating dosing in past 24 hours) / total woman-time on PrEP in active cohort = PrEP adherence rate (objective)

3 secondary outcomes

PrEP Initiation
Time frame: 18 months
PrEP Adherence (Peri-sexual)
Time frame: 3 months
PrEP Adherence (Subjective, Self-reported)
Time frame: 3 months

Results and safety

Results posted to the registry on 16 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pregnant Women Offered PrEP	200	200

Primary outcome: PrEP Retention

Time frame: 18 months. Number. Unit: participants

Measure	Pregnant Women Offered PrEP n = 200
Value	100

Population analysed: Participants who were retained on PrEP study and were on PrEP

Primary outcome: PrEP Adherence

Time frame: 3 months. Number. Unit: participants

Measure	Pregnant Women Offered PrEP n = 78
Value	25

Population analysed: Women who were adherent on PrEP at 3 months per DBS measure of TFV-DP (equivalent to 2+ days/week by pregnant or postpartum)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: We collected data every study visit (quarterly) until 12 months postpartum (up to 18 months from baseline enrollment in study). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pregnant Women Offered PrEP	10 of 200 (5%)	0 of 200 (0%)	0 of 200

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31813838Joseph Davey D, Myer L, Coates T. PrEP implementation in pregnant and post-partum women. Lancet HIV. 2020 Jan;7(1):e5-e6. doi: 10.1016/S2352-3018(19)30371-6. Epub 2019 Dec 5. No abstract available.
Results publication: PubMed 37795521Khadka N, Gorbach PM, Nyemba DC, Mvududu R, Mashele N, Javanbakht M, Nianogo RA, Aldrovandi GM, Bekker LG, Coates TJ, Myer L, Joseph Davey DL. Evaluating the use of oral pre-exposure prophylaxis among pregnant and postpartum adolescent girls and young women in Cape Town, South Africa. Front Reprod Health. 2023 Sep 19;5:1224474. doi: 10.3389/frph.2023.1224474. eCollection 2023.
Results publication: PubMed 34085132Joseph Davey DL, Knight L, Markt-Maloney J, Tsawe N, Gomba Y, Mashele N, Dovel K, Gorbach P, Bekker LG, Coates TJ, Myer L. "I had Made the Decision, and No One was Going to Stop Me" -Facilitators of PrEP Adherence During Pregnancy and Postpartum in Cape Town, South Africa. AIDS Behav. 2021 Dec;25(12):3978-3986. doi: 10.1007/s10461-021-03320-x. Epub 2021 Jun 3.
Results publication: PubMed 35138678Joseph Davey DL, Mvududu R, Mashele N, Lesosky M, Khadka N, Bekker LG, Gorbach P, Coates TJ, Myer L. Early pre-exposure prophylaxis (PrEP) initiation and continuation among pregnant and postpartum women in antenatal care in Cape Town, South Africa. J Int AIDS Soc. 2022 Feb;25(2):e25866. doi: 10.1002/jia2.25866.
Results publication: PubMed 34287756Moran A, Mashele N, Mvududu R, Gorbach P, Bekker LG, Coates TJ, Myer L, Joseph Davey D. Maternal PrEP Use in HIV-Uninfected Pregnant Women in South Africa: Role of Stigma in PrEP Initiation, Retention and Adherence. AIDS Behav. 2022 Jan;26(1):205-217. doi: 10.1007/s10461-021-03374-x. Epub 2021 Jul 21.
Results publication: PubMed 36947792Haribhai S, Khadka N, Mvududu R, Mashele N, Bekker LG, Gorbach P, Coates TJ, Myer L, Joseph Davey DL. Psychosocial determinants of pre-exposure prophylaxis use among pregnant adolescent girls and young women in Cape Town, South Africa: A qualitative study. Int J STD AIDS. 2023 Jul;34(8):548-556. doi: 10.1177/09564624231152776. Epub 2023 Mar 22.

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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 Phase 4 study testing TDF-FTC and Counselling on PrEP in antenatal and postnatal care 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 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 1 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Mar 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?

PrEP Retention (time frame: 18 months). 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 NCT03826199, which also lists 6 linked publications.

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 1 Dec 2023.