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.
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.
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DOI：
10.1007/s10461-022-03834-y
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发表时间：
2023-03
影响因子：
4.4
通讯作者：
Steiner, Markus J.
中科院分区：
文献类型：
--
作者：
Deese, Jennifer;Chen, Pai Lien;Gao, Xiaoming;Heffron, Renee;Hobbs, Marcia;Lapple, Dana;Jaspan, Heather;Miller, Ashley;Nair, Gonasagrie;Onono, Maricianah;Palanee-Phillips, Thesla;Reddy, Krishnaveni;Steiner, Markus J.
避孕选择和艾滋病毒结局的证据（ECHO）试验发现，随机接受注射肌内长效醋酸甲羟孕酮（DMPA-IM），铜宫内节育器（Cu-IUD）或左炔诺孕酮（LNG）植入的妇女之间的艾滋病毒感染风险没有实质性差异。我们使用一个客观的无安全套阴道性行为的标记物评估了随机分组后的性行为。我们在三个地点的458名ECHO参与者中进行了一项子研究（开普敦，约翰内斯堡，基苏穆）评价无安全套阴道性交的频率，通过在第6个月和末次访视时收集的阴道拭子中的前列腺特异性抗原（PSA）检测来测量，以及自我报告的无安全套阴道性交与PSA检测的一致性，我们采用Cochran-Mantel-Haenszel检验和校正的广义Logistic增长曲线模型，按随机分组比较PSA检测频率和PSA与自我报告的无安全套阴道性行为的一致性。与Cu-IUD组（21%）和LNG植入组（24%）相比，DMPA-IM组（16%）检测到PSA的频率较低，尽管在考虑预先规定的多重检验标准时，未调整模型中的结果无统计学意义。DMPA-IM和LNG植入组之间的PSA检测存在显著差异（在校正模型中，比值比为0.61（95% CI 0.40，0.94））。在自我报告的无安全套阴道性行为和PSA检测之间存在中度不一致，这在随机分组中相似。这些数据表明，随机分配到Cu-IUD和LNG植入的女性可能比随机分配到DMPA-IM的女性更频繁地进行无避孕套性行为。可检测的PSA和自我报告的性行为之间的不一致性对未来艾滋病毒预防研究的设计具有重要意义。
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. We evaluated post-randomization sexual behavior using an objective marker of condomless vaginal sex in a subset of participants. We 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. We 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. PSA was detected less frequently in the DMPA-IM (16%), compared to the Cu-IUD (21%) and LNG implant (24%) groups, although results were not statistically significant in the unadjusted model when accounting for pre-specified multiple-testing criteria. There were significant differences in PSA detection between the DMPA-IM and LNG-implant groups (odds ratio 0.61 (95% CI 0.40, 0.94) in the adjusted model. There was moderate discordance between self-reported condomless vaginal sex and detection of PSA that was similar across randomized groups. These data suggest that women randomized to Cu-IUD and LNG implant may have had condomless sex more frequently than women randomized to DMPA-IM. The discordance between detectable PSA and self-reported sexual behaviour has important implications for design of future HIV prevention studies.
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