The Depo Provera and Beyond study is a collaboration between multiple research institutes in the United States, South Africa and Australia (FHI 360, the University of Cape Town, Virginia Commonwealth University, Oregon Health and Science University and Burnet Institute) and clinical sites in South Africa, the Dominican Republic and Brazil (MatCH Research Unit, Setshaba Research Centre, Wits Reproductive Health and HIV Institute, Effective Care Research Unit, Qhakaza Mbokodo Research Clinic, Profamilia and University of Campinas).
The aims of this study are to investigate the effects of different long-acting contraceptives on the female genital tract (i) microbiome, (ii) inflammatory profile, (iii) epithelial barrier integrity and (iv) 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: The Evidence for Contraceptive Options and HIV Outcomes (ECHO) trial; the Sayana Press Extension trial; and the Lower Dose DMPA PK/PD study.
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 randomized 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.
Dr Jennifer Deese (Principal Investigator)
Dr Kavita Nanda
Dr Charles Morrison
UNIVERSITY OF CAPE TOWN:
Professor Jonathan Blackburn
VIRGINIA COMMONWEALTH UNIVERSITY:
Dr Gregory Buck
Dr Myrna Serrano
Dr Jerome Strauss
Dr Kimberly Jefferson
OREGON HEALTH AND SCIENCE UNIVERSITY:
Dr David Erikson
MATCH RESEARCH UNIT:
Prof Jennifer Smit
SETSHABA RESEARCH CENTRE:
Dr Khatija Ahmed
WITS REPRODUCTIVE HEALTH AND HIV INSTITUTE
Dr Thesla Palanee-Phillips
EFFECTIVE CARE RESEARCH UNIT
Prof Justus Hoffmeyr
QHAKAZA MBOKODO RESEARCH CLINIC:
Dr Sydney Sibiya
Lic. Vivian Brache
UNIVERSITY OF CAMPINAS:
Prof Luis Bahamondes
Depo and Beyond Study: National Institutes of Health (NIH)
ECHO clinical trial: Bill & Melinda 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, and UN Population Fund
Sayana Press Extension and Lower Dose DMPA clinical trials: FHI 360