Community-Based HIV VCT: South Africa

描述（由申请人提供）：no - od -09-058: NIH宣布为竞争性修订申请提供恢复法案资金。男性包皮环切术对艾滋病毒感染的保护作用可能是由于改善了生殖器卫生。我们建议评估在南非奥兰治农场不愿行包皮环切术的男性中进行性交后生殖器卫生研究的可行性。如果这种干预措施被证明能有效降低艾滋病毒感染风险，那么高流行环境中的男性可能会从改善生殖器卫生中获益。干预发展过程的第一步是测试性交后男性生殖器卫生的可行性。建议可行性研究的目的是评估性交后男性生殖器卫生程序的可行性和可接受性，参与者将被要求在性交后立即或至少12小时后练习。如果手术是可接受的，目标人群认为方便和可行，并且依从性高，那么在南非的年轻男性中，采用交替干预设计的预防性随机对照试验对性交后阴茎卫生对艾滋病毒发病率的影响的可行性将得到证实。感兴趣的结果是：1。能够接受阴茎清洁手术培训的志愿者比例。2. 参与者报告坚持性交后早期阴茎清洁的比例。3. 参与者报告坚持延迟性交后阴茎清洁的比例。4. 参与者赞成性交后阴茎清洗程序的做法的比例。5. 参与者报告伴侣接受这种做法的比例。6. 参与者在研究随访期间坚持性交后阴茎清洁的比例，通过阴茎拭子分析进行评估。几项随机对照试验研究表明，男性包皮环切术降低了感染艾滋病毒的风险，这可能是由于更好的生殖器卫生。我们将研究改善男性生殖器卫生的可行性，作为男性保护自己免受艾滋病毒感染的可能途径。如果我们发现男性能够在性行为后坚持洗手，我们将计划在以后的研究中测试这是否可以保护男性免受艾滋病毒感染。

DESCRIPTION (provided by applicant): NOT-OD-09-058: NIH Announces the Availability of recovery Act Funds for Competitive Revision Applications The protective effect of-male circumcision on HIV acquisition may be due to improved genital hygiene. We propose to evaluate the feasibility of a post-coital genital hygiene study among men unwilling to be circumcised in Orange Farm, South Africa. Men in high prevalence settings could potentially benefit from improved genital hygiene if this intervention proved to be efficacious in reducing HIV acquisition risk. The first step in the intervention development process is to test the feasibility of post-coital male genital hygiene. The aim of the proposed feasibility study is to evaluate the feasibility and acceptability of a post-coital male genital hygiene procedure, which participants will be asked to practice immediately post-coitus or at least 12 hours after. The feasibility of a prevention RCT with an alternating intervention design on the effect of post coital penile hygiene on HIV incidence among young males in South Africa will be substantiated if the procedure is acceptable, is deemed convenient and practicable by the target population, and if adherence is high. The outcomes of interest are: 1. Proportion of volunteers able to be trained to perform the penile cleansing procedure. 2. Proportion of participants reporting adherence to early post coital penile cleansing. 3. Proportion of participants reporting adherence to delayed post coital penile cleansing. 4. Proportion of participants favorable to the practice of the post coital penile cleansing procedure. 5. Proportion of participants reporting partner's acceptance of the practice. 6. Proportion of participants' adherent to the post coital penile cleansing during study follow-up as assessed by penile swabs analysis. Several RCT studies have shown that male circumcision lowers risk of HIV infection, and this may be due to better genital hygiene. We will study the feasibility of improving male genital hygiene as a possible way for men to protect themselves from HIV. If we find that men are able to practice consistent washing practices after sex, we will plan to test whether this might protect men from becoming HIV infected in a later study. PUBLIC HEALTH RELEVANCE: Several RCT studies have shown that male circumcision lowers risk of HIV infection, and this may be due to better genital hygiene. We will study the feasibility of improving male genital hygiene as a possible way for men to protect themselves from HIV. If we find that men are able to practice consistent washing practices after sex, we will plan to test whether this might protect men from becoming HIV infected in a later study.