Try out PMC Labs and tell us what you think. Learn More. To study adherence to product use prior to a Phase I microbicide trial, we recruited young men who have sex with men YMSM with a history of unprotected receptive anal intercourse RAI and provided them with 40 rectal applicators containing a placebo gel to use prior to RAI during a week period.
Ninety-five YMSM completed the trial. Based on an interactive voice response system, 88 participants had RAI Median 10 occasions using gel on By applicator counts the median gel use was Participants showed high adherence to gel use.
Three decades of condom promotion have failed to eliminate sexual transmission of HIV. Alternatives to condoms are badly needed for those who cannot or will not use them consistently. Typically, microbicides have been formulated as gels, foams, tablets or films that are administered in the vaginal or rectal lumen 2.
Unfortunately, a subsequent Phase IIb trial 4 failed to replicate themainly due to a lack of adherence to product use 5. Therefore, studying factors influencing adherence is very important for successful product use and implementation.
Rectal microbicide RM development has not advanced as rapidly as vaginal microbicide development.
Thus far, only Phase I safety and acceptability trials of RM have been completed 6 — 8. Prior studies have noted that a gel had more favorable ratings than a suppository as a microbicide delivery vehicle 10 and that 35mL is the maximum volume of a rectal gel that MSM would find acceptable for use prior to intercourse Although these acceptability estimates help inform RM trials, there is scant information on the use of RM or RM surrogates in real life circumstances.
Our study focused on young men who have sex with men YMSMespecially on those of ethnic-minority background, a population with high HIV prevalence and incidence 12 We targeted the subgroup for which RM are being developed: individuals who reported inconsistent condom use for receptive anal intercourse RAIthe sexual behavior most likely to lead to HIV infection The initial stage of our study had two main aims: firstly, to determine the prevalence of sexually transmitted infections STIs and anal and rectal pathologies that might facilitate HIV infection Stage 1A and secondly, to determine the acceptability of and adherence to a placebo gel delivered rectally prior to RAI Stage 1B.
In this report, we present the adherence for Stage 1B additional will be presented in other manuscripts currently in preparation. Study candidates were recruited between December and June from clinics, bars, clubs, and other locations e.
Advertisements were placed in newspapers and at community-based organizations, and volunteers from research studies who authorized future contacts were invited to call. Recruiters also used social media Facebook, Twitteradvertisements in Craigslist an online advertisement sitepostings in chat and dating sites for MSM, and smartphone applications. Recruitment materials indicated that the investigators were looking for YMSM ages 18—30 years willing to undergo a complete physical exam, including an anorectal exam, be tested for HIV, and answer questions about their medical and sexual history.
The eligibility screening script explained that the purpose of the study was to learn about the sexual health of YMSM and their feelings about inserting rectally a placebo gel resembling a to-be-developed microbicide gel prior to receptive anal sex.
Participants underwent pre-eligibility screening by phone or in person to determine age, same sex behavior, and pd negative HIV status.
Those who passed pre-screening were invited to the clinic for in-person screening Visit 1. Eligibility criteria included being sexually active operationalized as at least one RAI episode in the prior month and engaging in some potential risk behavior.
So as to cast a wide net for the epidemiological objective of Stage 1A i. After informed consent procedures, participants answered a medical history and received a physical exam including a digital rectal exam and anoscopy. In addition, participants completed a Web-based computer assisted self-interview CASI that included, among other topics, questions on demographics and sexual practices in the prior three months.
HIV counseling and condoms were provided. Participants returned to the clinic within 28 days Visit 2 and were informed of test. From those who received medical clearance as determined by negative HIV and STI tests, no known allergies to latex, parabens, or medications, and no other medical conditions that would make study participation unsafe and who stated they did not currently engage or plan to engage in condomless RAI with HIV-infected partners, we selected those fulfilling the more stringent eligibility criterion of having had condomless RAI within the prior three months.
This allowed us to focus on those with more recent potential risk and invite them to enroll in Stage 1B.
After undergoing a new informed consent process and update of medical history, a video teleconference was held to train them on the use of a phone-based Interactive Voice Response System IVRS to report product use at least weekly during the following three months. Next, participants received 20 single use rectal applicators, measuring 13 mm when plunger is fully depressed, pre-filled with 4 mL of HEC gel and instructions to insert the entire content of one applicator rectally within 90 minutes prior to each RAI episode.
No tests were used to verify applicator use. Six weeks after Visit 2, participants returned for the Mid-trial Follow-up Visit Visit 3 at which the medical history was reviewed and updated; any reported adverse event was further explored; a physical exam including digital rectal exam and anoscopy was performed; samples were collected for STI and HIV testing if clinically indicated; used and unused applicators were collected, counted and recorded; and 20 new rectal applicators containing HEC were dispensed.
All procedures of Visit 3 were repeated but no rectal applicators were dispensed at this time. Additionally, participants completed a new Web-based CASI that included questions on adherence to product use.
It covered the prior three months and included questions about of male and female partners, type of partner lover, one-night-stand, otherlubricant use, and of sexual occasions for different acts. At the end of the 3-month trial, another CASI was administered with questions about sexual behavior during the prior three months, including of occasions of RAI, condomless RAI, gel use prior to RAI, and reasons for lack of product use.
During the three months of the trial, sexual behavior was also assessed through IVRS: Participants were provided a toll-free phone and an individual participant ID. The system asked, among other things, of RAI occasions since the prior call and of occasions in which the gel was used.
Participants could leave a recorded message explaining the reasons for not using the gel. Responses were entered by pressing keys or by speech.
The system recorded date and time of call. Participants who did not call in six days received an automated follow-up call that prompted them to answer the questionnaire.
If no response was received within 24 hours, study coordinators were alerted via to contact the participant to inquire about missed calls and adherence to the study product regimen. Adherence to product use was also measured through the aggregate count of used and unused applicators returned to the clinic at Visits 3 and 4. If fewer than the 40 dispensed applicators were returned, this was noted, and participants were asked to report reasons for lack of return and whether the missing applicators had been used or not.
However, only the returned applicator count was used for our primary adherence analysis.
Descriptive demographic data were calculated and the 3 study sites were compared using ANOVAs for continuous and chi-square tests for dichotomous variables. Baseline and week follow-up sexual behaviors were compared using paired t-tests for continuous variables after log-transformation due to skewed distributions and McNemar tests for dichotomous variables.
Intraclass correlations were calculated to compare self-reported product use to actual returned and used applicators. We also examined whether sexual behavior outcomes reported in the IVRS data were congruent with follow-up CASI measurements, and we compared study drop-outs to those who completed each study stage to understand whether participants in these two groups differed on their demographic and sexual risk variables.
We used t-tests for continuous and chi-square tests for categorical variables for the above comparisons. The initial who both fulfilled eligibility criteria for Stage 1B and were available for a 3-month trial were enrolled in Stage 1B.
However, both scores correspond to having completed a partial college education on our 7-point scale. In sum, participants in the Stage 1B sample were very similar those in the larger original sample. Reasons for participant withdrawal included moving to another state, family problems, lack of time for study participation, or other reasons; others were lost to follow up despite repeated attempts to contact them.
As before, we compared the 95 HIV-negative participants who completed 1B to the 29 participants who did not on demographics and sexual risk behavior. Table I presents the demographic characteristics of 95 participants who completed Stage 1B. No African American participants identified as bisexual. The comparison between the two time periods shows no ificant changes in frequency of receptive anal sex or type of partner.
Yet, men reported having fewer sexual partners and fewer occasions of condomless RAI during the trial. There were no reports of lack of use due to product leaking out a common complaint among users of vaginal microbicidesbleeding, or burning or itching sensations. Of the 95 participants who completed the trial, 94 provided information about their sexual behavior and product use through IVRS.
The 95 participants who completed the 3-month trial received 40 applicators each. Based on returned applicator counts, there was a median of 12 used applicators returned. If any applicators were not returned, participants were asked how many unreturned applicators were used vs.
The most frequent reason for lack of applicator return was forgetting to do so. In four cases, the applicators were discarded by participant, grandmother, and Transportation Security Authority personnel.
Only one participant and the partner of another participant expressed reservations about having to return used applicators. Overall, there was convergence among the different measures of product use. Estimates obtained retrospectively at week CASI follow-up approximate those based on returned applicator counts.
Seventy-nine men reporting on applicator use in CASI also returned applicators at both time points. Of the 78 participants with data for all three measures, 4 reported exactly the same of applicators used, 35 reported a discrepancy of between 1 and 5 applicators, and 16 reported a discrepancy of between 6 and 10 applicators, and 23 reported a discrepancy of between 11 and 37 applicators See Figure 1.
YMSM with a history of inconsistent condom use during RAI had the chance to use in real- life circumstances a gel resembling a future rectal microbicide delivered with a rectal applicator. These are encouraging.
Although self-reports may be subject to social desirability and produce inflatedwe observed convergence among obtained with different methods. Among those who had multiple data sources, the concordance of different measures increases the credibility of the.
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