Feasibility of Vaginal Progesterone to Reduce HIV-Associated Preterm Birth

NCT02970552 | Completed Phase 4 Results FDA Drug

• 3 other identifiers: 16-21741R21HD090987-01Z 31606
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

PreTerm Birth

Keywords

PreTerm Birth; HIV; Vaginal Progesterone; ART; Adherence; Feasibility

Outcome Measures

Primary Outcomes (1)

• 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

  Enrollment through 36th gestational week, an overall total of up to 17 weeks

Secondary Outcomes (12)

• Acceptability of Use of Vaginal Progesterone (VP)

  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

  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)

  Late in pregnancy or postpartum

• Acceptability of a Vaginal Medication to Prevent Preterm Birth

  Visit 9.0 (36 weeks of gestation)

• Reported Barriers to Adherence to Study Product

  Visit 9.0 (36 weeks of gestation)

Study Arms (2)

Vaginal Progesterone

ACTIVE COMPARATOR

Daily self-administered vaginal progesterone

Drug: Vaginal Progesterone

Placebo

PLACEBO COMPARATOR

Daily self-administered indistinguishable placebo

Drug: Placebo

Interventions

Vaginal Progesterone DRUG

200 mg micronized vaginal progesterone suppository

Vaginal Progesterone

Placebo DRUG

Indistinguishable placebo vaginal suppository

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Kamwala District Health Centre

Lusaka, Zambia

Location

Related Publications (1)

• 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.

  PMID: 28729911 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: Joan Price, MD, MPH
• Organization: University of North Carolina at Chapel Hill

joni@email.unc.edu

919-962-4717

Study Officials

• Jeffrey Stringer, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: November 22, 2016
• Study Start: July 1, 2017
• Primary Completion: November 13, 2018
• Study Completion: November 13, 2018
• Last Updated: February 6, 2020
• Results First Posted: February 6, 2020

Record last verified: 2019-03

Locations

ZA (1)