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Depo Provera 510X288

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. 

Other research

Partners

Funding partner: Depo and Beyond study

National Institutes of Health (NIH)

Funding partners: ECHO clinical trial

  • Gates Foundation 

  • US Agency for International Development and the President’s Emergency Plan for AIDS Relief 

  • Swedish International Development Cooperation Agency 

  • South African Medical Research Council 

  • UN Population Fund 

Funding partner: Sayana Press Extension and Lower Dose DMPA clinical trials

FHI 360 

Collaborators

  • FHI 360 

  • University of Cape Town 

  • Virginia Commonwealth University 

  • Oregon Health and Science University 

  • Match Research Unit 

  • Setshaba Research Centre 

  • Wits Reproductive Health and HIV Institute 

  • Effective Care Research Unit 

  • Qhakaza Mbokodo Research Clinic 

  • Profamilia 

  • University of Campinas 

Project contacts

Dr Lindi Masson

Dr Lindi Masson

Co-Primary Investigator
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Project team

Dr Lindi Masson

Dr Lindi Masson

Co-Principal Investigator
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Jenna Wilson

Jenna Wilson

Research Assistant
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Kavita Nanda

Kavita Nanda

Co-Principal Investigator
FHI 360
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Jennifer Deese

Jennifer Deese

Co-Principal Investigator
Pfizer
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Gregory Buck

Gregory Buck

Co-Principal Investigator
Virginia Commonwealth University
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Myrna Serrano

Myrna Serrano

Co-Principal Investigator
https://medschool.vcu.edu/about/portfolio/details/mgserrano/
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Pai-Lien Chen

Pai-Lien Chen

Lead Biostatistician
FHI 360
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 Jerome Strauss

Jerome Strauss

Co-Investigator
University of Pennsylvania
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Jennifer Smit

Jennifer Smit

Clinical Site Principal Investigator
MatCH Research Unit
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Khatija Ahmed

Khatija Ahmed

Clinical Site Principal Investigator
Setshaba Research Center
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Mags Beksinska

Mags Beksinska

Clinical Site Principal Investigator
MatCH Research Unit
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David Edwards

David Edwards

Bioinformatician
Virginia Commonwealth University
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Jonathan Blackburn

Jonathan Blackburn

Co-Investigator
University of Cape Town
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Rushil Harryparsad

Rushil Harryparsad

PhD student
University of Cape Town
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Bahiah Meyer

Bahiah Meyer

PhD student
University of Cape Town
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Andrea Abrahams

Andrea Abrahams

PhD student
University of Cape Town
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Monalisa Manhanzva

Monalisa Manhanzva

Postdoctoral Fellow
University of Cape Town
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Tariq Ganief

Tariq Ganief

Researcher
University of Cape Town
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Linda-Gail Bekker

Linda-Gail Bekker

Clinical Site Principal Investigator
Desmond Tutu Health Foundation
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Thesla Palanee-Phillips

Thesla Palanee-Phillips

Clinical Site Principal Investigator
Wits Reproductive Health and HIV Institute
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Cheryl Louw

Cheryl Louw

Clinical Site Principal Investigator
Madibeng Centre for Research
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Justus Hofmeyer

Justus Hofmeyer

Clinical Site Principal Investigator
Effective Care Research Unit
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Pearl Selepe

Pearl Selepe

Clinical Site Principal Investigator
Aurum Institute
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Philip Kotze

Philip Kotze

Clinical Site Principal Investigator
Qhakaza Mbokodo Research Clinic
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Sydney Sibiya

Sydney Sibiya

Clinical Site Principal Investigator
Qhakaza Mbokodo Research Clinic
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Celia Mehou-Loko

Celia Mehou-Loko

Project Manager
University of Cape Town
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Florence Lefebvre D'Hellencourt

Florence Lefebvre D'Hellencourt

Project Manager
FHI 360
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David Erikson

David Erikson

Collaborator
Oregon Health & Science University
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Christel Tinguely

Christel Tinguely

Collaborator
University of Cape Town
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Rubina Bunjun

Rubina Bunjun

Collaborator
University of Cape Town
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