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.
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.
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