HIV PreventionNCT03832530
Periconception PrEP for HIV-exposed Ugandan Women
A study testing Safer conception counseling inclusive of periconception PrEP in people with HIV Prevention, run by Massachusetts General Hospital at 1 site in Uganda.
Trial summary
In this mixed-methods research study, the study team will offer comprehensive safer conception services to 150 HIV-uninfected women reporting an HIV-infected or high-risk partner and personal or partner plans for pregnancy in rural Uganda to evaluate prevalence and determinants of uptake and adherence (tenofovir… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- HIV Prevention
- What is being tested?
- Safer conception counseling inclusive of periconception PrEP
- 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
- 150 participants
- Where
- 1 siteUganda
- Study dates
- 27 Nov 2017to 30 Dec 2020
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Currently pregnant
- HIV-positive
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adherence to Periconception HIV Risk-reduction Among Uninfected Women in Rural Uganda
In this mixed-methods research study, the study team will offer comprehensive safer conception services to 150 HIV-uninfected women reporting an HIV-infected or high-risk partner and personal or partner plans for pregnancy in rural Uganda to evaluate prevalence and determinants of uptake and adherence (tenofovir plasma concentration >40ng/mL, opening pill device to take >80% of dispensed pills) to PrEP and other safer conceptions strategies among Ugandan women exposed to HIV.
Read the detailed description
The study plans to enroll 150 HIV-uninfected women with an HIV-positive or HIV-serostatus unknown partner and personal or partner pregnancy plans. Eligible women will participate in comprehensive safer conception counseling including offering daily, oral TDF/FTC as PrEP. The primary outcomes are to evaluate uptake of and adherence to periconception PrEP among HIV-exposed women in rural Uganda.
To accomplish this, women will participate in quarterly study visits, HIV and pregnancy testing, questionnaires and safer conception/adherence group counseling sessions. Participants will be eligible to initiate PrEP at any time during the first 6 months of the 9-month study follow-up period. Participants who initiate PrEP will use an electronic pill cap to measure daily adherence and will be asked to give blood samples to measure plasma TFV at quarterly study visits.
For women who become pregnant in the first 9 months, investigators will follow them up through completion of pregnancy to evaluate PrEP use, pregnancy and infant outcomes.
Study duration will be a maximum 19 month follow-up period (through pregnancy outcome) .
Investigators will offer objective sexually transmitted infection (STI) testing to all participants in order to measure the prevalence, incidence, and factors associated with STIs. Investigators will compare incidence among women who choose and who do not choose PrEP. Investigators will also measure the number of episodes of condomless sex each month as a mediator variable for STI development.
- Conditions
- HIV Prevention
- Being tested
- Safer conception counseling inclusive of periconception PrEP
- Keywords
- PrEP, conception, prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safer conception counseling inclusive of periconception PrEPBehavioural
Observational evaluation of factors associated with uptake of and adherence to daily, oral TDF/FTC PrEP and other safer conception methods (including: CHCT, ART for the infected partner, and uptake of contraception for those who decide not to conceive during follow-up) over 9 month. Maximum 19 month follow-up period (through pregnancy outcome).
| Study group | Role | What they receive |
|---|---|---|
| HIV-uninfected women | Experimental | A sample of 150 women, aged 18-35, likely to be fertile based on reproductive health history, with reported personal or partner desire to have a child in the next year and who self-reports having a relationship with a partner she reports as HIV-infected or likely to be HIV-infected (e.g. taking medicine daily, goes to clinic routinely, has HIV-infected partners, he has implied that he is "sick" but has not disclosed). All women are offered comprehensive safe conception counseling -- this is the intervention -- inclusive of daily oral TDF/FTC as PrEP. Receives: Behavioral: Safer conception counseling inclusive of periconception PrEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of PrEP
Measure prevalence (measured by the proportion of women who collect the first 3 month supply of drug) TDF/FTC PrEP for safer conception
Measured: 9 months
Secondary outcomes (2)
Adherence to PrEP, daily pill taking behavior
We will measure the proportion of women who achieve daily adherence to at least 80% of PrEP through electronic pill count measurement
Measured: 9 months
Adherence to PrEP, plasma levels
We will measure the proportion of women who achieve TFV plasma levels consistent with taking medication (detectable) and taking enough medication to confer protection (=>40ng/mL).
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start27 Nov 2017
- Primary completion1 Apr 2019
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Safer conception counseling
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mbarara University of Science and Technology
- Responsible party
- Principal investigator, Lynn T Matthews, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832530
- Sponsor's protocol ID
- 2017P001853
- Status last verified
- May 2021
- First submitted
- 7 Dec 2018
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Matthews LT, Atukunda EC, Owembabazi M, Kalyebera KP, Psaros C, Chitneni P, Hendrix CW, Marzinke MA, Anderson PL, Isehunwa OO, Hurwitz KE, Bennett K, Muyindike W, Bangsberg DR, Haberer JE, Marrazzo JM, Bwana MB. High PrEP uptake and objective longitudinal adherence among HIV-exposed women with personal or partner plans for pregnancy in rural Uganda: A cohort study. PLoS Med. 2023 Feb 16;20(2):e1004088. doi: 10.1371/journal.pmed.1004088. eCollection 2023 Feb.
PubMed 36795763Atukunda EC, Owembabazi M, Pratt MC, Psaros C, Muyindike W, Chitneni P, Bwana MB, Bangsberg D, Haberer JE, Marrazzo J, Matthews LT. A qualitative exploration to understand barriers and facilitators to daily oral PrEP uptake and sustained adherence among HIV-negative women planning for or with pregnancy in rural Southwestern Uganda. J Int AIDS Soc. 2022 Mar;25(3):e25894. doi: 10.1002/jia2.25894.
PubMed 35324081
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Periconception HIV Risk-reduction Among Uninfected Women in Rural Uganda
- ClinicalTrials.gov ID
- NCT03832530
- Acronym / sponsor ID
- 2017P001853
- Conditions
- HIV Prevention
- Keywords
- PrEP, conception, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Mbarara University of Science and Technology
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 6 Feb 2019 (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.
In this mixed-methods research study, the study team will offer comprehensive safer conception services to 150 HIV-uninfected women reporting an HIV-infected or high-risk partner and personal or partner plans for pregnancy in rural Uganda to evaluate prevalence and determinants of uptake and adherence (tenofovir plasma concentration >40ng/mL, opening pill device to take >80% of dispensed pills) to PrEP and other safer conceptions strategies among Ugandan women exposed to HIV.
Detailed description
The study plans to enroll 150 HIV-uninfected women with an HIV-positive or HIV-serostatus unknown partner and personal or partner pregnancy plans. Eligible women will participate in comprehensive safer conception counseling including offering daily, oral TDF/FTC as PrEP. The primary outcomes are to evaluate uptake of and adherence to periconception PrEP among HIV-exposed women in rural Uganda.
To accomplish this, women will participate in quarterly study visits, HIV and pregnancy testing, questionnaires and safer conception/adherence group counseling sessions. Participants will be eligible to initiate PrEP at any time during the first 6 months of the 9-month study follow-up period. Participants who initiate PrEP will use an electronic pill cap to measure daily adherence and will be asked to give blood samples to measure plasma TFV at quarterly study visits.
For women who become pregnant in the first 9 months, investigators will follow them up through completion of pregnancy to evaluate PrEP use, pregnancy and infant outcomes.
Study duration will be a maximum 19 month follow-up period (through pregnancy outcome) .
Investigators will offer objective sexually transmitted infection (STI) testing to all participants in order to measure the prevalence, incidence, and factors associated with STIs. Investigators will compare incidence among women who choose and who do not choose PrEP. Investigators will also measure the number of episodes of condomless sex each month as a mediator variable for STI development.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Safer conception counseling
| Arm | Type | Receives |
|---|---|---|
| HIV-uninfected women | Experimental | Behavioral: Safer conception counseling inclusive of periconception PrEPA sample of 150 women, aged 18-35, likely to be fertile based on reproductive health history, with reported personal or partner desire to have a child in the next year and who self-reports having a relationship with a partner she reports as HIV-infected or likely to be HIV-infected (e.g. taking medicine daily, goes to clinic routinely, has HIV-infected partners, he has implied that he is "sick" but has not disclosed). All women are offered comprehensive safe conception counseling -- this is the intervention -- inclusive of daily oral TDF/FTC as PrEP. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Currently pregnant
- HIV-positive
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 |
|---|---|---|
| Safer conception counseling inclusive of periconception PrEPObservational evaluation of factors associated with uptake of and adherence to daily, oral TDF/FTC PrEP and other safer conception methods (including: CHCT, ART for the infected partner, and uptake of contraception for those who decide not to conceive during follow-up) over 9 month. Maximum 19 month follow-up period (through pregnancy outcome). | Behavioural | HIV-uninfected women |
Primary outcome
Uptake of PrEP
Time frame: 9 months
Measure prevalence (measured by the proportion of women who collect the first 3 month supply of drug) TDF/FTC PrEP for safer conception
2 secondary outcomes
Adherence to PrEP, daily pill taking behavior
Time frame: 9 months
Adherence to PrEP, plasma levels
Time frame: 9 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 26 May 2021.
- Derived from this study: PubMed 36795763Matthews LT, Atukunda EC, Owembabazi M, Kalyebera KP, Psaros C, Chitneni P, Hendrix CW, Marzinke MA, Anderson PL, Isehunwa OO, Hurwitz KE, Bennett K, Muyindike W, Bangsberg DR, Haberer JE, Marrazzo JM, Bwana MB. High PrEP uptake and objective longitudinal adherence among HIV-exposed women with personal or partner plans for pregnancy in rural Uganda: A cohort study. PLoS Med. 2023 Feb 16;20(2):e1004088. doi: 10.1371/journal.pmed.1004088. eCollection 2023 Feb.
- Derived from this study: PubMed 35324081Atukunda EC, Owembabazi M, Pratt MC, Psaros C, Muyindike W, Chitneni P, Bwana MB, Bangsberg D, Haberer JE, Marrazzo J, Matthews LT. A qualitative exploration to understand barriers and facilitators to daily oral PrEP uptake and sustained adherence among HIV-negative women planning for or with pregnancy in rural Southwestern Uganda. J Int AIDS Soc. 2022 Mar;25(3):e25894. doi: 10.1002/jia2.25894.
Related trials for HIV Prevention
Not yet recruiting
Prevention and Rapid Outreach for Treatment, Engagement, and Care Transition From the Emergency Department
Opioid Overdose Prevention, HIV Prevention and Care
Active, not recruitingPhase 2
Gabapentin to Reduce Alcohol and Improve Viral Load Suppression
HIV, Heavy Drinking
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
RecruitingPhase 1/2
Trial of Allogeneic Reduced-Intensity, HLA-Haploidentical Allogeneic Hematopoietic Cell Bone Marrow Transplantation Followed by Graft-versus-Host-Disease (GVHD) Prophylaxis With Cyclophosphamide, Bortezomib and Maraviroc for Hematologic Malignancies ...
HIV, Hematologic Malignancies
Recruiting
Feasibility Study Comparing One vs Two Probes for TA Among Cervical Cancer Screen Positive WLWH in C1001P-CS5 Rwanda
HIV (Human Immunodeficiency Virus), HPV
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 Safer conception counseling inclusive of periconception PrEP in people with HIV Prevention, run by Massachusetts General Hospital at 1 site in Uganda.
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 0 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: finished, as of the sponsor's last update on 26 May 2021. 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 Uganda. 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?
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?
Uptake of PrEP (time frame: 9 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 NCT03832530, which also lists 2 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 26 May 2021.