Depo Provera and Beyond
The Depo Provera and Beyond study is a collaboration between multiple research institutes in the United States, South Africa and Australia, and clinical sites in South Africa, the Dominican Republic and Brazil.
Objective
The aims of this study are to investigate the effects of different long-acting contraceptives on the female genital tract including:
- microbiome
- inflammatory profile
- epithelial barrier integrity
- HIV target cell recruitment and activation.
Another aim is to investigate interactions between contraceptives and the microbiome and inflammation that impact HIV acquisition risk.
This study includes clinical specimens and metadata that were collected in three randomised control trials:
- Evidence for Contraceptive Options and HIV Outcomes (ECHO) trial
- Sayana Press Extension trial
- Lower Dose DMPA PK/PD study.
Timeline
2018–ongoing.
Approach
The ECHO clinical trial aimed to evaluate HIV incidence among women randomised to receive 3-monthly intramuscular doses of 150 mg of depot medroxyprogesterone acetate (DMPA), the copper intrauterine device or the levonorgestrel implant in South Africa, Kenya, Zambia and Swaziland.
The Depo Provera and Beyond sub-study is analysing samples collected from 168 South African participants at baseline, and month 1 and month 3 following contraceptive initiation. We additionally aim to analyse samples collected at baseline from 177 women who subsequently acquired HIV and 708 controls who remained HIV-uninfected during the trial.
Sayana Press Extension is a randomised trial to evaluate the contraceptive efficacy of Sayana Press (104 mg DMPA) injected every 4 months among women in the Dominican Republic, Chile and Brazil. Our sub-study is analysing samples collected from 23 participants in Brazil.
Lower Dose DMPA PK/PD Study aimed to evaluate suppression of ovulation of MPA after a single subcutaneous injection of DMPA-SQ 105 mg, 104 mg, 75 mg or 45 mg in the Dominican Republic, Chile and Brazil. Our sub-study is analysing samples collected from 40 participants in Brazil and the Dominican Republic.
Featured publications
Genital inflammatory status and the innate immune response to contraceptive initiation
American Journal of Reproductive Immunology
Nina Radzey et al
Prevalence and incidence of sexually transmitted infections among South African women initiating injectable and long-acting contraceptives
PLoS ONE
Rushil Harryparsad et al
Other research
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Effect of contraceptive methods on the vaginal microbiome and host immune factors
Effect of contraceptive methods on the vaginal microbiome and host immune factors
Partners
Funding partner: Depo and Beyond study
National Institutes of Health (NIH)
Funding partners: ECHO clinical trial
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Gates Foundation
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US Agency for International Development and the President’s Emergency Plan for AIDS Relief
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Swedish International Development Cooperation Agency
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South African Medical Research Council
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UN Population Fund
Funding partner: Sayana Press Extension and Lower Dose DMPA clinical trials
FHI 360
Collaborators
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FHI 360
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University of Cape Town
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Virginia Commonwealth University
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Oregon Health and Science University
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Match Research Unit
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Setshaba Research Centre
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Wits Reproductive Health and HIV Institute
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Effective Care Research Unit
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Qhakaza Mbokodo Research Clinic
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Profamilia
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University of Campinas
Project contacts
Project team
Dr Lindi Masson
Co-Principal Investigator
Jenna Wilson
Research Assistant
Kavita Nanda
Co-Principal Investigator
FHI 360
Jennifer Deese
Co-Principal Investigator
Pfizer
Gregory Buck
Co-Principal Investigator
Virginia Commonwealth University
Myrna Serrano
Co-Principal Investigator
https://medschool.vcu.edu/about/portfolio/details/mgserrano/
Pai-Lien Chen
Lead Biostatistician
FHI 360
Jerome Strauss
Co-Investigator
University of Pennsylvania
Jennifer Smit
Clinical Site Principal Investigator
MatCH Research Unit
Khatija Ahmed
Clinical Site Principal Investigator
Setshaba Research Center
Mags Beksinska
Clinical Site Principal Investigator
MatCH Research Unit
David Edwards
Bioinformatician
Virginia Commonwealth University
Jonathan Blackburn
Co-Investigator
University of Cape Town
Rushil Harryparsad
PhD student
University of Cape Town
Bahiah Meyer
PhD student
University of Cape Town
Andrea Abrahams
PhD student
University of Cape Town
Monalisa Manhanzva
Postdoctoral Fellow
University of Cape Town
Tariq Ganief
Researcher
University of Cape Town
Linda-Gail Bekker
Clinical Site Principal Investigator
Desmond Tutu Health Foundation
Thesla Palanee-Phillips
Clinical Site Principal Investigator
Wits Reproductive Health and HIV Institute
Cheryl Louw
Clinical Site Principal Investigator
Madibeng Centre for Research
Justus Hofmeyer
Clinical Site Principal Investigator
Effective Care Research Unit
Pearl Selepe
Clinical Site Principal Investigator
Aurum Institute
Philip Kotze
Clinical Site Principal Investigator
Qhakaza Mbokodo Research Clinic
Sydney Sibiya
Clinical Site Principal Investigator
Qhakaza Mbokodo Research Clinic
Celia Mehou-Loko
Project Manager
University of Cape Town
Florence Lefebvre D'Hellencourt
Project Manager
FHI 360
David Erikson
Collaborator
Oregon Health & Science University
Christel Tinguely
Collaborator
University of Cape Town