HIV incidence among women using intramuscular depot medroxyprogesterone acetate, a copper intrauterine device, or a levonorgestrel implant for contraception: a randomised, multicentre, open-label trial.

What Was Tested

This randomized controlled trial looks at Copper (Supplement).

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.

Contraceptive supplies were donated by the Government of South Africa and US Agency for International Development.

Who Took Part

PubMed indexes the participants as teenagers, young adults and adults, women only.

Participants were assigned using an online randomisation system, which was accessed for each randomisation by study staff at each site.

The primary endpoint was incident HIV infection in the modified intention-to-treat population, including all randomised participants who were HIV negative at enrolment and who contributed at least one HIV test.

How the Study Was Run

The researchers set it up as a randomized, open-label and multicenter study.

Random assignment meant chance, not the researchers, decided who got Copper (Supplement) and who got the comparison, which limits bias.

Nothing was hidden in this open-label Copper (Supplement) study: the participants and staff both knew the treatment.

Running at several centres spread the Copper (Supplement) study over different clinics and patient groups.

The researchers did a randomised, multicentre, open-label trial across 12 research sites in eSwatini, Kenya, South Africa, and Zambia.

The primary safety endpoint was any serious adverse event or any adverse event resulting in method discontinuation, until the trial exit visit at 18 months and was assessed in all enrolled and randomly assigned women.

This study is registered with ClinicalTrials.gov, number NCT02550067.

What Was Measured

PubMed files the paper under topics including Eswatini, Family Planning Services, HIV Infections, Incidence, Intention to Treat Analysis, Intrauterine Devices, Copper and Kenya.

What This Means in Plain Language

The paper is a randomized, open-label and multicenter study of Copper (Supplement).

Results are reported in around 7 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2019 (Lancet (London, England)), a journal based in England.

More context: the Copper (Supplement) compound page, all human trials.