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Interactive Voice Response System: Data Considerations and Lessons Learned During a Rectal Microbicide Placebo Adherence Trial for Young Men Who Have Sex With Men.

ABSTRACT: BACKGROUND:Rectal microbicides, if proven effective, may aid in reducing human immunodeficiency virus (HIV) incidence; however, demonstration of efficacy and effectiveness is contingent on accurate measurement of product adherence. Delays in self-report, in particular, may affect the accuracy of behavioral data. OBJECTIVE:The aim of this study was to capitalize on mobile phone use by young men who have sex with men (YMSM), and examine the use of an interactive voice response system (IVRS) by YMSM aged 18-30 years enrolled in a multisite, 12-week microbicide safety and acceptability trial. METHODS:YMSM (N=95) enrolled across 3 sites (Boston, Pittsburgh, and San Juan) were asked to report their use of an applicator applied placebo rectal gel product during receptive anal intercourse (RAI) using the IVRS. IVRS was available in Spanish and English. After the 12-week trial, we examined whether IVRS problems were associated with YMSM's sociodemographic characteristics (eg, age, race and ethnicity, and education), sexual behavior, or recruitment site. We used a multinomial logistic regression to compare YMSM who experienced no IVRS problems (n=40) with those who reported one IVRS problem (n=25) or two or more IVRS problems (n=30). RESULTS:We recorded 1494 IVRS calls over 12 weeks. Over half of the participants (55/95; 58%) experienced challenges using the IVRS during the 12-week trial. YMSM reporting greater RAI occasions during the trial were more likely to experience one (odds ratio [OR]=1.08, 95% CI (1.02-1.14); P ?.01) or more (OR=1.10, 95% CI (1.03-1.16); P ?.001) IVRS challenges. Greater educational attainment was associated with multiple IVRS challenges (OR=7.08, 95% CI (1.6-31.6); P ?.01). Participants in the Puerto Rico site were most likely to report multiple IVRS problems. CONCLUSIONS:Although IVRS was a useful data collection technology in our trial, several challenges experienced by English and Spanish speaking YMSM diminish its overall acceptability. We discuss strategies to optimize future development of IVRS data quality protocols based on lessons learned.

SUBMITTER: Bauermeister J

PROVIDER: S-EPMC5482925 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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Interactive Voice Response System: Data Considerations and Lessons Learned During a Rectal Microbicide Placebo Adherence Trial for Young Men Who Have Sex With Men.

Bauermeister Jose J Giguere Rebecca R Leu Cheng-Shiun CS Febo Irma I Cranston Ross R Mayer Kenneth K Carballo-Diéguez Alex A

Journal of medical Internet research 20170609 6

<h4>Background</h4>Rectal microbicides, if proven effective, may aid in reducing human immunodeficiency virus (HIV) incidence; however, demonstration of efficacy and effectiveness is contingent on accurate measurement of product adherence. Delays in self-report, in particular, may affect the accuracy of behavioral data.<h4>Objective</h4>The aim of this study was to capitalize on mobile phone use by young men who have sex with men (YMSM), and examine the use of an interactive voice response syste ...[more]

PMID: 28600275

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Project description:Trials to assess microbicide safety require strict adherence to prescribed regimens. If adherence is suboptimal, safety cannot be adequately assessed. MTN-017 was a phase 2, randomized sequence, open-label, expanded safety and acceptability crossover study comparing 1) daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), 2) daily use of reduced-glycerin 1% tenofovir (RG-TFV) gel applied rectally, and 3) RG-TFV gel applied before and after receptive anal intercourse (RAI)-if participants had no RAI in a week, they were asked to use two doses of gel within 24 hours. Product use was assessed by mixed methods including unused product return count, text messaging reports, and qualitative plasma TFV pharmacokinetic (PK) results. Convergence interviews engaged participants in determining the most accurate number of doses used based on product count and text messaging reports. Client-centered adherence counseling was also used. Participants (N = 187) were men who have sex with men and transgender women enrolled in the United States (42%), Thailand (29%), Peru (19%) and South Africa (10%). Mean age was 31.4 years (range 18-64 years). Based on convergence interviews, over an 8-week period, 94% of participants had ?80% adherence to daily tablet, 41% having perfect adherence; 83% had ?80% adherence to daily gel, 29% having perfect adherence; and 93% had ?80% adherence to twice-weekly use during the RAI-associated gel regimen, 75% having perfect adherence and 77% having ?80% adherence to gel use before and after RAI. Only 4.4% of all daily product PK results were undetectable and unexpected (TFV concentrations <0.31 ng/mL) given self-reported product use near sampling date. The mixed methods adherence measurement indicated high adherence to product use in all three regimens. Adherence to RAI-associated rectal gel use was as high as adherence to daily oral PrEP. A rectal microbicide gel, if efficacious, could be an alternative for individuals uninterested in daily oral PrEP.

Dataset Information

Interactive Voice Response System: Data Considerations and Lessons Learned During a Rectal Microbicide Placebo Adherence Trial for Young Men Who Have Sex With Men.

Publications

Interactive Voice Response System: Data Considerations and Lessons Learned During a Rectal Microbicide Placebo Adherence Trial for Young Men Who Have Sex With Men.

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