PreTerm BirthPhase 4VPNCT02970552
Feasibility of Vaginal Progesterone to Reduce HIV-Associated Preterm Birth
A Phase 4 study testing Vaginal Progesterone in people with PreTerm Birth, run by University of North Carolina, Chapel Hill at 1 site in Zambia.
Trial summary
More than 1.5 million HIV-infected women become pregnant each year. Approximately half have access to antiretroviral therapy (ART), but all are at increased risk of preterm birth (PTB). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- PreTerm Birth
- What is being tested?
- Vaginal Progesterone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteZambia
- Study dates
- 1 Jul 2017to 13 Nov 2018
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- viable intrauterine pregnancy confirmed by ultrasound
- presentation to antenatal care prior to 24 weeks gestation
- antibody-confirmed HIV-1 infection
- initiating or continuing ART treatment in pregnancy
- ability and willingness to provide written informed consent
- willing to adhere to study visit schedule
Who cannot join
- multiple gestation
- non-research indication for antenatal progesterone (i.e. prior spontaneous PTB and/or cervical length <20mm on screening ultrasound)
- planned or in situ cervical cerclage
- evidence of threatened abortion, preterm labor, or ruptured membranes
- major fetal anomaly detected on screening ultrasound
- known uterine anomaly
- known or suspected allergy or contraindication to VP or placebo components
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Vaginal Progesterone to Reduce Preterm Birth Among Women Receiving Antiretroviral Therapy in Pregnancy
More than 1.5 million HIV-infected women become pregnant each year. Approximately half have access to antiretroviral therapy (ART), but all are at increased risk of preterm birth (PTB). Vaginal progesterone (VP) is a promising and cost-effective intervention to prevent PTB that should be studied in this high-risk population. This pilot study will provide critical insight into the feasibility of a phase III trial by determining whether women are willing to participate, to adhere to study drug, and to complete follow-up.
Read the detailed description
This will be a mixed method study to evaluate the feasibility and acceptability of a trial of VP to prevent PTB among HIV-infected Zambian women. To assess the feasibility of a full-scale clinical trial, the investigators will implement a pilot two-arm, double-masked, placebo-controlled trial of VP among HIV-infected women in antenatal care in Lusaka, Zambia. Participants will be randomly assigned to either daily self-administered VP or indistinguishable placebo prior to 24 weeks gestational age. In this pilot study, the investigators will be able to estimate study uptake, adherence to study product and protocol, and study retention. To assess the acceptability of a trial to test VP among HIV-infected women in Zambia, the investigators will employ a qualitative approach of longitudinal semi-structured interviews among women agreeing to trial participation and one-time semi-structured interviews (SSIs) among those who decline to participate.
- Conditions
- PreTerm Birth
- Being tested
- Vaginal Progesterone, Placebo
- Keywords
- PreTerm Birth, HIV, Vaginal Progesterone, ART, Adherence, Feasibility
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal ProgesteroneDrug
200 mg micronized vaginal progesterone suppository
PlaceboDrug
Indistinguishable placebo vaginal suppository
| Study group | Role | What they receive |
|---|---|---|
| Vaginal Progesterone | Active comparator | Daily self-administered vaginal progesterone Receives: Drug: Vaginal Progesterone |
| Placebo | Placebo comparator | Daily self-administered indistinguishable placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate Adherence to Study Product
Number of participants who achieved adequate adherence to study product, defined as proper self-administration of at least 80% of prescribed study product doses, as measured by a dye stain assay of returned applicators
Measured: Enrollment through 36th gestational week, an overall total of up to 17 weeks
Secondary outcomes (12)
Acceptability of Use of Vaginal Progesterone (VP)
Semi-structured interviews will be held with a random sample of participants who enroll and those who decline enrollment.
Measured: At enrollment (20-24 weeks gestation), at 28 weeks gestation, and at 36 weeks gestation
Reported Barriers and Facilitators to Adherence to Study Product, Returning Used Applicators, and Retention in the Study
Number of participants reporting barriers and facilitators to study product adherence, returning used applicators, and retention in the study during a semi-structured interview. Participants were selected for an interview based on their overall adherence rates, including those with excellent adherence throughout the study and those with lower adherence rates early or late in their participation. A trained female staff member conducted each 30-minute interview using an interview guide. Interviews were audiotaped, transcribed, and translated into English as necessary.
Measured: Late in pregnancy or postpartum
Summary of Reported Knowledge, Attitudes, and Practices Related to HIV, Antiretroviral Therapy (ART), Risk of Preterm Birth, and Participation in Placebo Controlled Randomized Clinical Trials (RCTs)
Number of participants reporting attitudes and practices related to participation in placebo controlled RCTs during a semi-structured interview. Participants were selected for an interview based on their overall adherence rates, including those with excellent adherence throughout the study and those with lower adherence rates early or late in their participation. A trained female staff member conducted each 30-minute interview using an interview guide. Participants were asked about their attitudes toward participation in the study and research in general as HIV-infected women taking ART and at risk of preterm birth, but they were not specifically asked about their underlying knowledge of these conditions. Interviews were audio-taped, transcribed, and translated into English as necessary.
Measured: Late in pregnancy or postpartum
Acceptability of a Vaginal Medication to Prevent Preterm Birth
Number of participants reporting specific attitudes about medications for the prevention of preterm birth (PTB), including acceptability of daily vaginal administration as measured on the Exit Satisfaction Survey using a Likert scale of five possible options ranging from strongly agree to strongly disagree. The form included a range of facial illustrations to facilitate comprehension of the answer choices, particularly for illiterate participants.
Measured: Visit 9.0 (36 weeks of gestation)
Reported Barriers to Adherence to Study Product
Number of participants reporting challenges with taking the study medication as measured on the Exit Satisfaction Survey. The survey was administered by a study nurse who asked each participant what was the hardest part about taking the medication and presented all possible answer choices. Participant were asked to select only one answer.
Measured: Visit 9.0 (36 weeks of gestation)
Sensitivity, Specificity, and Predictive Value of Dose Diaries
Comparison of self-reported adherence rates (Dose Diary/DD) and use of returned applicators measured by dye stain assay (DSA)
Measured: Enrollment through 36th gestational week, an overall total of up to 17 weeks
Enrollment of Eligible Participants
Number of eligible participants who enrolled in the study
Measured: Screening through Enrollment
Ascertainment of Date of Delivery and Infant Vital Status
Number of women for whom date of delivery and infant vital status at birth was ascertained
Measured: Visit 10.0 (Delivery)
Preliminary Efficacy
Number of participants delivering before 34 and 37 completed weeks of gestation, grouped based on whether the participant went into labor spontaneously or was induced by a provider
Measured: Visit 10.0 (Delivery)
Birth Weight
Number of participants with neonates weighing less than 2500 grams at birth
Measured: Visit 10.0 (Delivery)
Stillbirth
Number of participants who experienced a stillbirth
Measured: Visit 10.0 (Delivery)
Adverse Events
Number of women experiencing a serious adverse event or event that resulted in study product discontinuation
Measured: Enrollment through Visit 10.0 (Delivery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study start1 Jul 2017
- Primary completion13 Nov 2018
- Study completion13 Nov 2018
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 (1)Papers the sponsor has linked to this study.
- Other trials for PreTerm BirthStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Stringer, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970552
- Sponsor's protocol ID
- 16-2174
- Other IDs
- 1R21HD090987-01, Z 31606
- Acronym
- VP
- Status last verified
- Mar 2019
- First submitted
- 17 Nov 2016
- Last updated
- 6 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Price JT, Mollan KR, Fuseini NM, Freeman BL, Mulenga HB, Corbett AH, Vwalika B, Stringer JSA. Vaginal progesterone to reduce preterm birth among HIV-infected pregnant women in Zambia: a feasibility study protocol. Pilot Feasibility Stud. 2017 Jul 18;4:21. doi: 10.1186/s40814-017-0170-7. eCollection 2018.
PubMed 28729911
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Vaginal Progesterone to Reduce Preterm Birth Among Women Receiving Antiretroviral Therapy in Pregnancy
- ClinicalTrials.gov ID
- NCT02970552
- Acronym / sponsor ID
- VP / 16-2174
- Conditions
- PreTerm Birth
- Keywords
- PreTerm Birth, HIV, Vaginal Progesterone, ART, Adherence, Feasibility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 13 Nov 2018 (actual)
- Study completion
- 13 Nov 2018 (actual)
- First posted
- 22 Nov 2016 (estimated)
- Results
- Posted 6 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
More than 1.5 million HIV-infected women become pregnant each year. Approximately half have access to antiretroviral therapy (ART), but all are at increased risk of preterm birth (PTB). Vaginal progesterone (VP) is a promising and cost-effective intervention to prevent PTB that should be studied in this high-risk population. This pilot study will provide critical insight into the feasibility of a phase III trial by determining whether women are willing to participate, to adhere to study drug, and to complete follow-up.
Detailed description
This will be a mixed method study to evaluate the feasibility and acceptability of a trial of VP to prevent PTB among HIV-infected Zambian women. To assess the feasibility of a full-scale clinical trial, the investigators will implement a pilot two-arm, double-masked, placebo-controlled trial of VP among HIV-infected women in antenatal care in Lusaka, Zambia. Participants will be randomly assigned to either daily self-administered VP or indistinguishable placebo prior to 24 weeks gestational age. In this pilot study, the investigators will be able to estimate study uptake, adherence to study product and protocol, and study retention. To assess the acceptability of a trial to test VP among HIV-infected women in Zambia, the investigators will employ a qualitative approach of longitudinal semi-structured interviews among women agreeing to trial participation and one-time semi-structured interviews (SSIs) among those who decline to participate.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal Progesterone | Active comparator | Drug: Vaginal ProgesteroneDaily self-administered vaginal progesterone |
| Placebo | Placebo comparator | Drug: PlaceboDaily self-administered indistinguishable placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age or older
- viable intrauterine pregnancy confirmed by ultrasound
- presentation to antenatal care prior to 24 weeks gestation
- antibody-confirmed HIV-1 infection
- initiating or continuing ART treatment in pregnancy
Key exclusion criteria (7 listed)
- multiple gestation
- non-research indication for antenatal progesterone (i.e. prior spontaneous PTB and/or cervical length <20mm on screening ultrasound)
- planned or in situ cervical cerclage
- evidence of threatened abortion, preterm labor, or ruptured membranes
- major fetal anomaly detected on screening ultrasound
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 |
|---|---|---|
| Vaginal Progesterone200 mg micronized vaginal progesterone suppository | Drug | Vaginal Progesterone |
| PlaceboIndistinguishable placebo vaginal suppository | Drug | Placebo |
Primary outcome
Adequate Adherence to Study Product
Time frame: Enrollment through 36th gestational week, an overall total of up to 17 weeks
Number of participants who achieved adequate adherence to study product, defined as proper self-administration of at least 80% of prescribed study product doses, as measured by a dye stain assay of returned applicators
12 secondary outcomes
Acceptability of Use of Vaginal Progesterone (VP)
Time frame: At enrollment (20-24 weeks gestation), at 28 weeks gestation, and at 36 weeks gestation
Reported Barriers and Facilitators to Adherence to Study Product, Returning Used Applicators, and Retention in the Study
Time frame: Late in pregnancy or postpartum
Summary of Reported Knowledge, Attitudes, and Practices Related to HIV, Antiretroviral Therapy (ART), Risk of Preterm Birth, and Participation in Placebo Controlled Randomized Clinical Trials (RCTs)
Time frame: Late in pregnancy or postpartum
Acceptability of a Vaginal Medication to Prevent Preterm Birth
Time frame: Visit 9.0 (36 weeks of gestation)
Reported Barriers to Adherence to Study Product
Time frame: Visit 9.0 (36 weeks of gestation)
Sensitivity, Specificity, and Predictive Value of Dose Diaries
Time frame: Enrollment through 36th gestational week, an overall total of up to 17 weeks
Enrollment of Eligible Participants
Time frame: Screening through Enrollment
Ascertainment of Date of Delivery and Infant Vital Status
Time frame: Visit 10.0 (Delivery)
Preliminary Efficacy
Time frame: Visit 10.0 (Delivery)
Birth Weight
Time frame: Visit 10.0 (Delivery)
Stillbirth
Time frame: Visit 10.0 (Delivery)
Adverse Events
Time frame: Enrollment through Visit 10.0 (Delivery)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28729911Price JT, Mollan KR, Fuseini NM, Freeman BL, Mulenga HB, Corbett AH, Vwalika B, Stringer JSA. Vaginal progesterone to reduce preterm birth among HIV-infected pregnant women in Zambia: a feasibility study protocol. Pilot Feasibility Stud. 2017 Jul 18;4:21. doi: 10.1186/s40814-017-0170-7. eCollection 2018.
- Individual participant dataSharing planned: Undecided
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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.
Jeffrey Stringer, MD principal investigator
University of North Carolina, Chapel Hill
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 Vaginal Progesterone in people with PreTerm Birth, run by University of North Carolina, Chapel Hill at 1 site in Zambia.
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 7 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 6 Feb 2020. 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 Zambia. 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. Some participants in this study may receive a placebo. 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 6 Feb 2020). 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?
Adequate Adherence to Study Product (time frame: Enrollment through 36th gestational week, an overall total of up to 17 weeks). 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 NCT02970552, 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 6 Feb 2020.