Vaginal progesterone to reduce preterm birth among HIV-infected pregnant women in Zambia: a feasibility study protocol Public Deposited

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  • Freeman, Bethany L
    • Affiliation: School of Medicine, Department of Obstetrics and Gynecology
    • Other Affiliation: Division of Global Women’s Health
  • Vwalika, Bellington
    • Affiliation: School of Medicine, Department of Obstetrics and Gynecology
    • Other Affiliation: Division of Global Women’s Health
  • Price, Joan T
    • Affiliation: School of Medicine, Department of Obstetrics and Gynecology
    • Other Affiliation: Division of Global Women’s HealthDepartment of Obstetrics and Gynaecology, University Teaching Hospital, Lusaka, Zambia
  • Mollan, Katie R
    • Affiliation: School of Medicine, UNC Center for AIDS Research
  • Corbett, Amanda
    • Affiliation: Eshelman School of Pharmacy
  • Mulenga, Helen B
    • Other Affiliation: Pharmaceutical Society of Zambia, Lusaka, Zambia
  • Stringer, Jeffrey
    • Affiliation: School of Medicine, Department of Obstetrics and Gynecology
    • Other Affiliation: Division of Global Women’s Health
  • Fuseini, Nurain M
    • Affiliation: School of Medicine, Department of Obstetrics and Gynecology
    • Other Affiliation: Division of Global Women’s HealthDepartment of Obstetrics and Gynaecology, University Teaching Hospital, Lusaka, Zambia
Abstract
  • Abstract Background Women infected with HIV have a risk of preterm birth (PTB) that is twice that among uninfected women, and treatment with antiretroviral therapy (ART) may further increase this risk. Progesterone supplementation reduces the risk of preterm delivery in women who have a shortened cervix in the midtrimester. We propose to study the feasibility of a trial of vaginal progesterone (VP) to prevent PTB among HIV-infected women receiving ART in pregnancy. Given low adherence among women self-administering vaginal study product in recent microbicide trials, we plan to investigate whether adequate adherence to VP can be achieved prior to launching a full-scale efficacy trial. Methods and design One hundred forty HIV-infected pregnant women in Lusaka, Zambia, will be randomly allocated to daily self-administration of either VP or matched placebo, starting between 20 and 24 gestational weeks. The primary outcome will be adherence, defined as the proportion of participants who achieve at least 80% use of study product, assessed objectively with a validated dye stain assay that confirms vaginal insertion of returned single-use applicators. Secondary outcomes will be study uptake, retention, and preliminary efficacy. We will concurrently perform semi-structured interviews with participants enrolled in the study and with women who decline enrollment to assess the acceptability of VP to prevent PTB and of enrollment to a randomized controlled trial. Discussion We hypothesize that VP could prevent PTB among women receiving ART in pregnancy. In preparation for a trial to test this hypothesis, we plan to assess whether participants will be adherent to study product and protocol. Trial registration ClinicalTrial.gov, NCT02970552 .
Date of publication
Identifier
  • doi:10.1186/s40814-017-0170-7
Resource type
  • Article
Rights statement
  • In Copyright
Rights holder
  • The Author(s).
Language
  • English
Bibliographic citation
  • Pilot and Feasibility Studies. 2017 Jul 18;4(1):21
Publisher
  • BioMed Central
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