Behavioral Effects of Different Contraceptive Methods and HIV Acquisition: An Ancillary Study of the ECHO* Randomized Trial

Abstract

BackgroundThe ECHO trial randomised 7829 women to depot medroxyprogesterone acetate (DMPA-IM), the copper intrauterine device (IUD) and the levonorgestrel (LNG) implant (1:1:1) and found no clear difference in HIV incidence between these three groups. We have previously hypothesized that oligo-amenorrhoea induced by DMPA-IM may have a protective effect on HIV acquisition. The aim of this ancillary study was to assess the effects of DMPA-IM, the IUD and the LNG implant on menstrual symptoms and sexual behavior and to correlate these with HIV acquisition.Methods At the Effective Care Research Unit (ECRU) in South Africa, women already randomised to DMPA-IM, the copper IUD and the LNG implant (1:1:1) were asked to participate. Participants completed a 28-day symptom and behavior diary following their one-month ECHO trial visit and returning it at their 3-month follow-up visit. HIV acquisition data were retrieved from ECHO trial records.ResultsOf 487 women enrolled on the ancillary study, 390 (80%) completed their daily diary; 130, 133, and 127 received DMPA-IM, IUD, and LNG implant, respectively. Thirty-three (8·4%) of these women acquired HIV. Women on the progestin-only contraceptives were more likely to experience amenorrhoea, as expected, and were less likely to have intra-menstrual coitus than IUD users (p < 0·001 for DMPA-IM vs IUD and P = 0·002 for implant vs IUD). Overall coital frequency was highest and condom usage lowest among DMPA-IM users. Intra-menstrual coitus correlated positively, and duration of menstruation correlated negatively, with HIV acquisition, although these effects were not statistically significant (p=0·09 and p=0·079, respectively).ConclusionsFindings support the hypothesis that oligo-amenorrhoea and the associated reduced intra-menstrual coitus may mitigate the potential for an increased biological risk of HIV acquisition with DMPA-IM but more evidence is needed. Study registration number: PACTR201706001651380

Effects of three contraceptive methods on depression and sexual function: An ancillary study of the ECHO randomized trial

“…The protocol for this study was published in BMJ Open in 2018 11 . The study is ancillary to the ECHO trial, which was a large multicenter RCT with three parallel arms (1:1:1).…”

“…The protocol for this study was published in BMJ Open in 2018. 11 The study is ancillary to the ECHO trial, which was a large multicenter RCT with three parallel arms (1:1:1). In the ECHO trial, participants were randomized to three contraceptive methods (IUD, DMPA‐IM, and LNG implant) and the effects on HIV incidence and pregnancy rates were compared (ECHO trial registration: NCT02550067.…”

“… 9 We calculated that we would need at least 158 participants in each arm to detect a difference with 80% power between any of the three arms. 11 Stata Statistical Software V.15 (StataCorp., College Station, TX, USA) 17 was used for analysis, which was performed by YB. We used standard BDI‐II thresholds to categorize any depression (≥14), moderate depression (≥20) and severe depression (≥29) 12 ; and the standard ASEX threshold to categorize sexual dysfunction (≥19) among other suggested criteria.…”

“…For the ancillary study, we assumed a reduction in the incidence of depression with the alternative contraceptive methods compared with DMPA‐IM of 50% based on a rate of depression with DMPA‐IM of 26.5% from a previous study conducted in our setting 9 . We calculated that we would need at least 158 participants in each arm to detect a difference with 80% power between any of the three arms 11 . Stata Statistical Software V.15 (StataCorp., College Station, TX, USA) 17 was used for analysis, which was performed by YB.…”