Martinez Omar, Isabel Fernandez M, Wu Elwin, Carballo-Diéguez Alex, Prado Guillermo, Davey Adam, Levine Ethan, Mattera Brian, Lopez Nikki, Valentin Omar, Murray Ashley, Sutton Madeline
Temple University's School of Social Work, 1301 Cecil B. Moore Avenue, Ritter Annex, 505, Philadelphia, PA, 19122, USA.
Nova Southeastern University, 2000 South Dixie Highway, Miami, FL, 33133, USA.
Trials. 2018 Apr 5;19(1):218. doi: 10.1186/s13063-018-2582-y.
Latino men who have sex with men (MSM) experienced a 13% increase in HIV diagnoses from 2010 to 2014, more than any other racial/ethnic subgroup of MSM in the United States. If current HIV diagnoses rates persist, about one in four Latino MSM in the United States will be diagnosed with HIV during their lifetime. Although some efficacious HIV prevention interventions for Latino MSM exist, none have focused on couples. This paper describes the protocol of a randomized controlled trial (RCT) to test the preliminary efficacy of a couple-based HIV prevention intervention that is culturally tailored for Latino men and their same-sex partners.
The RCT will determine the preliminary efficacy of Connecting Latinos en Pareja (CLP) to increase the proportion of anal sex acts that are HIV protected (i.e., anal sex acts in which condoms, pre-exposure prophylaxis (PrEP), treatment as prevention (TasP), or a combination thereof, are used to reduce risk of HIV transmission). CLP builds upon previous couple-based interventions with white and black MSM by incorporating biomedical prevention techniques, such as PrEP and TasP, implementing a framework responsive to the couple's serostatus, and addressing the socio-cultural factors that influence HIV risk among Latino MSM. We also include input from community stakeholders, members of the target population, and a community advisory board as part of intervention development. Assessments will be conducted at baseline, and 3- and 6-months post-intervention to examine the intervention effects on outcomes (HIV-protected sex acts), and factors potentially mediating or moderating intervention effects.
This paper describes an innovative RCT that incorporates multiple HIV prevention techniques for Latino MSM in couples, regardless of serostatus. The ongoing involvement of community stakeholders, members of the target population, and a community advisory board is emphasized, and plans for widespread dissemination and application of findings into practice are discussed.
Trial registration: NCT03048838 . Registered on 3 February 2017.
2010年至2014年期间，与男性发生性关系的拉丁裔男性（MSM）的艾滋病毒诊断率上升了13%，高于美国任何其他种族/族裔的男男性接触亚群体。如果目前的艾滋病毒诊断率持续下去，美国约四分之一的拉丁裔男男性接触者在其一生中将被诊断出感染艾滋病毒。虽然存在一些针对拉丁裔男男性接触者的有效艾滋病毒预防干预措施，但没有一项是针对伴侣的。本文描述了一项随机对照试验（RCT）的方案，以测试一种针对拉丁裔男性及其同性伴侣进行文化调适的基于伴侣的艾滋病毒预防干预措施的初步疗效。
该随机对照试验将确定“携手拉丁裔伴侣”（CLP）增加受艾滋病毒保护的肛交行为比例（即使用避孕套、暴露前预防（PrEP）、治疗即预防（TasP）或其组合以降低艾滋病毒传播风险的肛交行为）的初步疗效。CLP在先前针对白人和黑人男男性接触者的基于伴侣的干预措施基础上进行改进，纳入了生物医学预防技术，如PrEP和TasP，实施了一个针对伴侣血清学状态的框架，并解决了影响拉丁裔男男性接触者艾滋病毒风险的社会文化因素。我们还将社区利益相关者、目标人群成员和社区咨询委员会的意见纳入干预措施的制定过程。评估将在基线、干预后3个月和6个月进行，以检查干预措施对结果（受艾滋病毒保护的性行为）的影响，以及可能介导或调节干预效果的因素。
本文描述了一项创新的随机对照试验，该试验为拉丁裔男男性接触者伴侣纳入了多种艾滋病毒预防技术，无论其血清学状态如何。强调了社区利益相关者、目标人群成员和社区咨询委员会的持续参与，并讨论了将研究结果广泛传播并应用于实践的计划。
试验注册：NCT03048838。于2017年2月3日注册。
