HIV PreventionPhase 4NCT03194308
Safer Conception for Women - Understanding Use of Periconception PrEP
A Phase 4 study testing PrEP for Safer Conception in people with HIV Prevention and Conception, run by Massachusetts General Hospital at 1 site in South Africa.
Trial summary
Women who choose to conceive with an infected or unknown serostatus partner in HIV-endemic settings need prevention strategies to reduce periconception HIV acquisition risk. Women at high risk for acquiring HIV during pregnancy need risk reduction strategies to protect themselves and their babies. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention, Conception
- What is being tested?
- PrEP for Safer Conception
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteSouth Africa
- Study dates
- 13 Nov 2017to 21 Jul 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female, Aged 18-35 years
- Not pregnant, HIV-uninfected
- Likely to be fertile based on responses to reproductive history assessment
- Not on a long-acting family planning method
- Likely to have a child in the next year, either by response to modified CDC Pregnancy Risk Assessment [2-5]), or meeting the other inclusion criteria.
- With a stable (>= 6 months) partner she reports as HIV-infected or HIV-serostatus unknown, (if >1 desired pregnancy partner, we will ask her to identify the most likely pregnancy partner- based on her own assessment of sexual frequency, fertility, etc.)
- Able to participate in the informed consent process
- Fluent in English or isiZulu
Who cannot join
- Living at or planning to relocate to a location incompatible with study participation in the next year
- Active drug or alcohol use that, in the opinion of the research study team, would interfere with adherence to study requirements
- Active illness requiring systemic treatment and/or hospitalization within 30 days prior to study entry that in the opinion of the research study team, might otherwise interfere with adherence to study requirements
- Inability to adhere to the study schedule and/or study procedures
- Enrolment in studies which may conflict with their participation in this proposed study.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Maternal, Adolescent, and Child Health Research Unit (MRU)
Durban, KwaZulu-Natal, 4001
About this study
Official title: Safer Conception for Women: PrEP Uptake/Adherence to Reduce Periconception HIV Risk for South African Women
Women who choose to conceive with an infected or unknown serostatus partner in HIV-endemic settings need prevention strategies to reduce periconception HIV acquisition risk. Women at high risk for acquiring HIV during pregnancy need risk reduction strategies to protect themselves and their babies. Evaluating uptake of and adherence to antiretrovirals as pre-exposure prophylaxis in this population is crucial to understanding whether and how this novel prevention strategy should be incorporated into HIV-risk reduction packages for at- risk women planning or with pregnancy.
Read the detailed description
In HIV-endemic settings, many HIV-uninfected women choose to conceive with an HIV-infected or unknown-serostatus partner. For a woman who cannot depend on a partner to test, initiate and adhere to ART, sex without condoms puts her at high risk of acquiring HIV and increases the risk of perinatal transmission to her child. Daily, oral TDF/FTC PrEP dramatically reduces a woman's risk of HIV-acquisition and is the only female-controlled option for reducing the risk of periconception HIV-acquisition. Understanding whether daily, oral PrEP is feasible for uninfected women seeking pregnancy is critical to reducing HIV incidence among women and their children.
Placebo-controlled trials identified adherence as a major challenge to long-term PrEP use. However, women are eager for prevention strategies that allow for conception, and we hypothesize that adherence to a proven prevention strategy, for a limited time with the motivation to have a healthy child, will confer drug levels required to prevent HIV transmission. This project will inform whether daily, oral PrEP is a feasible HIV-prevention strategy for South African women who intend to conceive with risky partners. Given the repercussions of acquiring HIV during conception and pregnancy, this is an important step towards providing a key prevention strategy to women and their children.
- Conditions
- HIV Prevention, Conception
- Being tested
- PrEP for Safer Conception
- Keywords
- HIV risk reduction, Safer Conception, Pre-exposure prophylaxis, South Africa, Women, Reproductive Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEP for Safer ConceptionBehavioural
Evaluation of uptake of and adherence to PrEP and safer conception strategies including: CHCT, ART for the infected partner, and uptake of contraception for those who decide not to conceive by enrolled women, during periconception and pregnancy follow up.
| Study group | Role | What they receive |
|---|---|---|
| HIV-uninfected women | Other | A sample of 350 HIV-uninfected women who are not currently pregnant, in a stable relationship (≥6 months) with a self-reported infected or unknown serostatus partner and personal or partner plans for pregnancy in the next 12 months. Women will be offered safer conception counseling based on South African guidelines plus daily, oral tenofovir/emtricitabine (TDF/FTC) as pre-exposure prophylaxis (PrEP) during periconception and pregnancy. Receives: Behavioral: PrEP for Safer Conception |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of uptake of and adherence to PrEP
The primary objective will be the evaluation of uptake of (collection of one month's supply) and adherence to PrEP (measured by quarterly plasma tenofovir levels) by women, during periconception and pregnancy follow up.
Measured: minimum of 12 months through pregnancy outcome (maximum 21 months)
Secondary outcomes (1)
Safer Conception Strategies
Secondary outcomes include uptake of safer conception strategies including CHCT, ART for the infected partner, uptake of contraception for those who decide not to conceive; HIV transmission events, infant outcomes, and findings from qualitative interviews to further inform the conceptual framework for periconception PrEP uptake and adherence.
Measured: minimum of 12 months through pregnancy outcome (maximum 21 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start13 Nov 2017
- Primary completion21 Jul 2021
- Study completion21 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- All participants are assigned to the Safer Conception study intervention.
- Masking
- None (open label)
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), University of Witwatersrand, South Africa, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Lynn T Matthews, University of Alabama at Birmingham
- Investigators
- Lynn T Matthews, MD, MPH, Principal investigator, Mass General Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194308
- Sponsor's protocol ID
- 2016P001535
- Other IDs
- 1R01MH108412
- Status last verified
- Oct 2023
- First submitted
- 19 Jun 2017
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kwach B, Odoyo JB, Lauff AR, Omollo V, Rono B, Ogello V, Mann V, Kwena Z, Thomas K, Sharma M, Morton JF, Ngure K, Bukusi E, Mugwanya KK, PrEP Care Team OS. Evaluating the effectiveness of a One-Stop PrEP Care model to enhance HIV prevention: a protocol for a cluster-randomised trial in Kisumu County, Kenya. BMJ Open. 2025 Sep 8;15(9):e097792. doi: 10.1136/bmjopen-2024-097792.
PubMed 40921636Matthews LT, Jaggernath M, Kriel Y, Smith PM, Haberer JE, Baeten JM, Hendrix CW, Ware NC, Moodley P, Pillay M, Bennett K, Bassler J, Psaros C, Hurwitz KE, Bangsberg DR, Smit JA. Oral preexposure prophylaxis uptake, adherence, and persistence during periconception periods among women in South Africa. AIDS. 2024 Jul 15;38(9):1342-1354. doi: 10.1097/QAD.0000000000003925. Epub 2024 May 27.
PubMed 38752557Matthews LT, Jaggernath M, Kriel Y, Smith PM, O'Neil K, Haberer JE, Hendrix C, Baeten JM, Ware NC, Wirth K, Psaros C, Bangsberg DR, Smit JA. Protocol for a longitudinal study to evaluate the use of tenofovir-based PrEP for safer conception and pregnancy among women in South Africa. BMJ Open. 2019 Jul 26;9(7):e027227. doi: 10.1136/bmjopen-2018-027227.
PubMed 31350241
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safer Conception for Women: PrEP Uptake/Adherence to Reduce Periconception HIV Risk for South African Women
- ClinicalTrials.gov ID
- NCT03194308
- Acronym / sponsor ID
- 2016P001535
- Conditions
- HIV Prevention, Conception
- Keywords
- HIV risk reduction, Safer Conception, Pre-exposure prophylaxis, South Africa, Women, Reproductive Health
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), University of Witwatersrand, South Africa, National Institute of Mental Health (NIMH)
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 21 Jul 2021 (actual)
- Study completion
- 21 Jul 2021 (actual)
- First posted
- 21 Jun 2017 (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.
Women who choose to conceive with an infected or unknown serostatus partner in HIV-endemic settings need prevention strategies to reduce periconception HIV acquisition risk. Women at high risk for acquiring HIV during pregnancy need risk reduction strategies to protect themselves and their babies. Evaluating uptake of and adherence to antiretrovirals as pre-exposure prophylaxis in this population is crucial to understanding whether and how this novel prevention strategy should be incorporated into HIV-risk reduction packages for at- risk women planning or with pregnancy.
Detailed description
In HIV-endemic settings, many HIV-uninfected women choose to conceive with an HIV-infected or unknown-serostatus partner. For a woman who cannot depend on a partner to test, initiate and adhere to ART, sex without condoms puts her at high risk of acquiring HIV and increases the risk of perinatal transmission to her child. Daily, oral TDF/FTC PrEP dramatically reduces a woman's risk of HIV-acquisition and is the only female-controlled option for reducing the risk of periconception HIV-acquisition. Understanding whether daily, oral PrEP is feasible for uninfected women seeking pregnancy is critical to reducing HIV incidence among women and their children.
Placebo-controlled trials identified adherence as a major challenge to long-term PrEP use. However, women are eager for prevention strategies that allow for conception, and we hypothesize that adherence to a proven prevention strategy, for a limited time with the motivation to have a healthy child, will confer drug levels required to prevent HIV transmission. This project will inform whether daily, oral PrEP is a feasible HIV-prevention strategy for South African women who intend to conceive with risky partners. Given the repercussions of acquiring HIV during conception and pregnancy, this is an important step towards providing a key prevention strategy to women and their children.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants are assigned to the Safer Conception study intervention.
| Arm | Type | Receives |
|---|---|---|
| HIV-uninfected women | Other | Behavioral: PrEP for Safer ConceptionA sample of 350 HIV-uninfected women who are not currently pregnant, in a stable relationship (≥6 months) with a self-reported infected or unknown serostatus partner and personal or partner plans for pregnancy in the next 12 months. Women will be offered safer conception counseling based on South African guidelines plus daily, oral tenofovir/emtricitabine (TDF/FTC) as pre-exposure prophylaxis (PrEP) during periconception and pregnancy. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Female, Aged 18-35 years
- Not pregnant, HIV-uninfected
- Likely to be fertile based on responses to reproductive history assessment
- Not on a long-acting family planning method
- Likely to have a child in the next year, either by response to modified CDC Pregnancy Risk Assessment [2-5]), or meeting the other inclusion criteria.
Key exclusion criteria (5 listed)
- Living at or planning to relocate to a location incompatible with study participation in the next year
- Active drug or alcohol use that, in the opinion of the research study team, would interfere with adherence to study requirements
- Active illness requiring systemic treatment and/or hospitalization within 30 days prior to study entry that in the opinion of the research study team, might otherwise interfere with adherence to study requirements
- Inability to adhere to the study schedule and/or study procedures
- Enrolment in studies which may conflict with their participation in this proposed study.
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 for Safer ConceptionEvaluation of uptake of and adherence to PrEP and safer conception strategies including: CHCT, ART for the infected partner, and uptake of contraception for those who decide not to conceive by enrolled women, during periconception and pregnancy follow up. | Behavioural | HIV-uninfected women |
Primary outcome
Evaluation of uptake of and adherence to PrEP
Time frame: minimum of 12 months through pregnancy outcome (maximum 21 months)
The primary objective will be the evaluation of uptake of (collection of one month's supply) and adherence to PrEP (measured by quarterly plasma tenofovir levels) by women, during periconception and pregnancy follow up.
1 secondary outcome
Safer Conception Strategies
Time frame: minimum of 12 months through pregnancy outcome (maximum 21 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 40921636Kwach B, Odoyo JB, Lauff AR, Omollo V, Rono B, Ogello V, Mann V, Kwena Z, Thomas K, Sharma M, Morton JF, Ngure K, Bukusi E, Mugwanya KK, PrEP Care Team OS. Evaluating the effectiveness of a One-Stop PrEP Care model to enhance HIV prevention: a protocol for a cluster-randomised trial in Kisumu County, Kenya. BMJ Open. 2025 Sep 8;15(9):e097792. doi: 10.1136/bmjopen-2024-097792.
- Derived from this study: PubMed 38752557Matthews LT, Jaggernath M, Kriel Y, Smith PM, Haberer JE, Baeten JM, Hendrix CW, Ware NC, Moodley P, Pillay M, Bennett K, Bassler J, Psaros C, Hurwitz KE, Bangsberg DR, Smit JA. Oral preexposure prophylaxis uptake, adherence, and persistence during periconception periods among women in South Africa. AIDS. 2024 Jul 15;38(9):1342-1354. doi: 10.1097/QAD.0000000000003925. Epub 2024 May 27.
- Derived from this study: PubMed 31350241Matthews LT, Jaggernath M, Kriel Y, Smith PM, O'Neil K, Haberer JE, Hendrix C, Baeten JM, Ware NC, Wirth K, Psaros C, Bangsberg DR, Smit JA. Protocol for a longitudinal study to evaluate the use of tenofovir-based PrEP for safer conception and pregnancy among women in South Africa. BMJ Open. 2019 Jul 26;9(7):e027227. doi: 10.1136/bmjopen-2018-027227.
- Individual participant dataSharing planned: Undecided
Related trials for HIV Prevention
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking
HIV Testing, STI
Not yet recruiting
HC-HMP: Healthy Choices Implementation Trial
Alcohol Drinking, HIV Infections
Not yet recruitingPhase 4
NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
HIV Infections, Opioid Use Disorder
Active, not recruitingPhase 3
Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus)
HIV Infections
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.
Lynn T Matthews, MD, MPH principal investigator
Mass General Hosptial
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 PrEP for Safer Conception in people with HIV Prevention and Conception, run by Massachusetts General Hospital 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 8 inclusion and 5 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 23 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of uptake of and adherence to PrEP (time frame: minimum of 12 months through pregnancy outcome (maximum 21 months)). 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 NCT03194308, which also lists 3 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 23 Oct 2023.