Post-randomization Differences in Condomless Vaginal Sex Among Women Randomized to Intramuscular Depot Medroxyprogesterone Acetate Injections, a Copper Intrauterine Device or a Levonorgestrel Implant in the ECHO Trial.

What Was Tested

Researchers studied Copper (Supplement) in this randomized controlled trial publication.

The researchers evaluated post-randomization sexual behavior using an objective marker of condomless vaginal sex in a subset of participants.

The researchers conducted a sub-study among 458 ECHO participants at three sites (Cape Town, Johannesburg, Kisumu) to evaluate the frequency of condomless vaginal sex, measured by prostate specific antigen (PSA) detection in vaginal swabs, collected at the month 6 and final visit and the concordance of self-reported condomless vaginal sex with PSA detection, by randomized arm.

Why It Was Studied

The Evidence for Contraceptive Options and HIV Outcomes (ECHO) trial found no substantial difference in HIV acquisition risk between women randomised to injectable intramuscular depot medroxyprogesterone acetate (DMPA-IM), copper intrauterine device (Cu-IUD) or the levonorgestrel (LNG) implant.

The researchers compared PSA detection frequency and concordance of PSA and self-reported condomless vaginal sex, by randomized group using Cochran-Mantel-Haenszel tests and adjusted generalized logistic growth curve models.

Who Took Part

The study group was 458 participants.

PubMed tags the participants as both men and women.

How the Study Was Run

In design terms this was a randomized study.

The participants were allocated by chance, so the Copper (Supplement) group and the comparison group should start out alike.

What Was Measured

The Evidence for Contraceptive Options and HIV Outcomes (ECHO) trial found no substantial difference in HIV acquisition risk between women randomised to injectable intramuscular depot medroxyprogesterone acetate (DMPA-IM), copper intrauterine device (Cu-IUD) or the levonorgestrel (LNG) implant.

The researchers compared PSA detection frequency and concordance of PSA and self-reported condomless vaginal sex, by randomized group using Cochran-Mantel-Haenszel tests and adjusted generalized logistic growth curve models.

Topics PubMed links to this paper include Levonorgestrel, Medroxyprogesterone Acetate, Intrauterine Devices, Copper, Unsafe Sex, Prostate-Specific Antigen, HIV Infections and South Africa.

The authors tagged it with the keywords Contraception, Prostate specific antigen and Sexual behaviour.

What This Means in Plain Language

The paper is a randomized study of Copper (Supplement) in 458 participants.

With several hundred people or more, it is a fairly large study for this kind of research.

The publication is from 2023 (AIDS and behavior), a journal based in United States.

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