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Feasibility of Vaginal Progesterone to Reduce HIV-Associated Preterm Birth (VP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02970552
Recruitment Status : Completed
First Posted : November 22, 2016
Last Update Posted : March 6, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief 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). 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.

Condition or disease Intervention/treatment Phase
PreTerm Birth Drug: Vaginal Progesterone Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Z 31606 - A Pilot Study of Vaginal Progesterone to Reduce Preterm Birth Among Women Receiving Antiretroviral Therapy in Pregnancy
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : November 13, 2018
Actual Study Completion Date : November 13, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Vaginal Progesterone
Daily self-administered vaginal progesterone
Drug: Vaginal Progesterone
200 mg micronized vaginal progesterone suppository

Placebo Comparator: Placebo
Daily self-administered indistinguishable placebo
Drug: Placebo
Indistinguishable placebo vaginal suppository




Primary Outcome Measures :
  1. Proportion of women with adequate adherence [ Time Frame: daily for 16 weeks ]
    Adequate adherence to study product (at least 80% of prescribed study doses), defined as proper self-administration will be measured by a dye stain assay of returned applicators.


Secondary Outcome Measures :
  1. Acceptability of use of VP [ Time Frame: at enrollment (20-24 weeks gestation), at 28 weeks gestation, and at 36 weeks gestation ]
    Semi-structured interviews will be held with a random sample of participants who enroll and who decline enrollment.

  2. Preliminary efficacy [ Time Frame: 34 and 37 gestational weeks ]
    Proportion of participants in each arm delivering before 37 and before 34 completed weeks of gestation.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years of age or older
  2. viable intrauterine pregnancy confirmed by ultrasound
  3. presentation to antenatal care prior to 24 weeks gestation
  4. antibody-confirmed HIV-1 infection
  5. initiating or continuing ART treatment in pregnancy
  6. ability and willingness to provide written informed consent
  7. willing to adhere to study visit schedule

Exclusion Criteria:

  1. multiple gestation
  2. non-research indication for antenatal progesterone (i.e. prior spontaneous PTB and/or cervical length <20mm on screening ultrasound)
  3. planned or in situ cervical cerclage
  4. evidence of threatened abortion, preterm labor, or ruptured membranes
  5. major fetal anomaly detected on screening ultrasound
  6. known uterine anomaly
  7. known or suspected allergy or contraindication to VP or placebo components

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02970552


Locations
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Zambia
Kamwala District Health Centre
Lusaka, Zambia
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Jeffrey Stringer, MD University of North Carolina, Chapel Hill

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02970552     History of Changes
Other Study ID Numbers: 16-2174
1R21HD090987-01 ( U.S. NIH Grant/Contract )
First Posted: November 22, 2016    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by University of North Carolina, Chapel Hill:
PreTerm Birth
HIV
Vaginal Progesterone
ART
Adherence
Feasibility

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs