Approaches that will yield greater success when implementing self-administered electronic data capture ICT systems in the developing world with an illiterate or semi-literate population

The Information Technology (IT) Group at the Population Council responded to a need for a technology solution that would help researchers obtain more accurate responses to survey questions that concerned subject matter of a sensitive nature. The IT Group had three goals: (1) to enhance research by obtaining the best data possible, (2) to operate successfully in the local environment and be welcomed by the local populations, and (3) to increase the efficiency and cost-effectiveness of the survey process. This paper outlines approaches to consider when designing and implementing self-administered information and communications technology (ICT) questionnaires in developing countries, and reviews the problems and issues we encountered and how we overcame them. Many of the approaches outlined may also be used in general for ICT-related projects in the developing world. To meet future challenges, we have begun an effort to build a prototype system that would operate on a variety of devices—when connected to the internet or not (securely storing the data when the system is offline)—and provide an administrative application to step through simple screens to build a self-administered questionnaire with the most frequently used functions

Acceptability in microbicide and PrEP trials: Current status and a reconceptualization

Purpose of review: Assessment of acceptability is a central component of most oral PrEP and microbicide trials. In this paper we review current definitions and frameworks employed in acceptability research, discuss findings from recent studies of product acceptability and summarize trends in acceptability research. We conclude by offering a new framework for investigating product acceptability within clinical trials, one which considers product acceptability to be conceptually distinct from adherence. Recent findings: Although numerous studies have investigated product acceptability, a consensus is lacking regarding the definition and operationalization of the concept. In addition. fewer than half of the studies reviewed investigated actual candidate products. To the extent that an overall measure of acceptability is considered, the consensus is that most participants find the products acceptable. However, it is the rare study that investigates whether product adherence is associated with acceptability. Summary: Given that adherence is critical to the success of clinical trials, it is important to identify the extent to which acceptability is a factor in product usage and to ascertain which dimensions of acceptability—product attributes, dosing regimen, delivery mechanism, use attributes, partner’s attitudes, effect of product on the sexual encounter, product-related norms—if any, affect adherence

Validation of a dye stain assay for vaginally inserted hydroxyethylcellulose-filled microbicide applicators

Background: The reliability and validity of self-reports of vaginal microbicide use are questionable given the explicit understanding that participants are expected to comply with study protocols. Our objective was to optimize the use of Population Council\u27s previously validated dye stain assay (DSA) and related procedures, and to establish predictive values for the DSAs ability to identify vaginally inserted single-use, low-density polyethylene microbicide applicators filled with hydroxyethylcellulose gel. Methods: Applicators, inserted by 252 female sex workers enrolled in a microbicide feasibility study in Southern India, served as positive controls for optimization and validation experiments. Before validation, optimal dye concentration and staining time were ascertained. Three validation experiments were conducted to determine sensitivity, specificity, and negative and positive predictive values. Results: The dye concentration of 0.05% (wt/vol) FD&C Blue No. 1 Granular Food Dye (Prime Ingredients, Inc, Saddlebrook, NJ) and staining time of 5 seconds were determined to be optimal and were used for the 3 validation experiments. There were a total of 1848 possible applicator readings across validation experiments; 1703 (92.2%) applicator readings were correct. On average, the DSA performed with 90.6% sensitivity, 93.9% specificity, and had a negative predictive value of 93.8% and a positive predictive value of 91.0%. No statistically significant differences between experiments were noted. Conclusions: The DSA was optimized and successfully validated for use with single use, low-density polyethylene applicators filled with hydroxyethylcellulose gel. We recommend including the DSA in future microbicide trials involving vaginal gels so as to identify participants who have low adherence to dosing regimens. In doing so, we can develop strategies to improve adherence as well as investigate the association between product use and efficacy

To tell or not to tell: Male partner engagement in a Phase 3 microbicide efficacy trial in South Africa

Gender norms that privilege men\u27s sexual power and pleasure, and distrust of condom use in intimate relationships, leave women vulnerable to HIV and other sexually transmitted infections. Vaginal microbicides allow women to exert a degree of control over their sexual health, through responsibility for product insertion as well as the possibility of covert use. In practice, however, the uptake of new HIV-prevention products is heavily influenced by partnership dynamics. This paper presents a secondary analysis of data from two qualitative sub-studies conducted during a Phase 3 microbicide efficacy trial in South Africa. Using transcripts from in-depth interviews and focus group discussions with 278 female trial participants and 27 male partners, we investigated the extent to which women disclosed microbicide use to their partners, and the level and types of male engagement with microbicide use. Most women chose to communicate with their partners about the trial, but the timing and content of associated discussions differed according to their motivation for disclosure. Men provided their partners with both moral and practical support, but reported a desire for greater involvement in decision-making surrounding microbicide uptake and use. The findings inform recommendations for constructive male participation in future trials and, ultimately, introduction of a marketed product

Characteristics of female sex workers in southern India willing and unwilling to participate in a placebo gel trial

Respondent-driven sampling was used to recruit female sex workers (FSWs) for a community survey conducted in southern India. After survey completion, participants were given a brochure describing a clinical trial that entailed daily use of a placebo vaginal gel for four months. This study assessed predictors of screening among survey respondents, predictors of enrollment among those eligible for the trial, and predictors of visit attendance and retention among those enrolled. FSWs who reported having symptoms of sexually transmitted infections (STI), engaging in sex work in the past month, and living in a subdistrict easily accessible by public transportation with a high concentration of FSWs, were more likely to screen. FSWs who had never been tested for HIV were more likely to enroll. This analysis suggests that the primary reason FSWs participated in the trial was a desire for health care—not other factors hypothesized to be important, e.g., HIV risk perception and poverty status

Using a 2-stage strategy with respondent-driven sampling to recruit a hard-to-reach population for a placebo microbicide gel clinical trial in Nellore, Andhra Pradesh (India)

Traditional recruitment methods for microbicide efficacy trials are labor intensive and may fail to reach high-risk hard-to-reach populations. We report duration of recruitment and lessons learned from a two-stage process to recruit female sex workers (FSWs) into a placebo microbicide trial, and examined characteristics associated with successful recruitment of peers who screened for and enrolled in the trial. FSWs were first recruited via respondent-driven sampling (RDS) to complete a survey and subsequently invited to screen for enrollment into a placebo microbicide trial taking place at a local clinic. It took 6 months to enroll 267 participants into the trial. Successful recruiters of peers who enrolled were more likely to have enrolled themselves (AOR 2.0, CI 1.3–2.9) and less likely to visit Nellore city (AOR 0.5, CI 0.3–0.9). Recruitment of FSWs via a two-stage recruitment strategy with RDS can be a good option for future clinical trials

An evaluation of methods to improve the reporting of adherence in a placebo gel trial in Andhra Pradesh, India

Female sex workers (FSWs) were recruited for a 4-month placebo vaginal gel trial in Nellore, India. Two experiments explored if prior knowledge of biomarkers for unprotected sex and insertion of gel applicators would yield more accurate self-reports. A third experiment compared self-reports of gel use and adherence levels between FSWs randomly assigned to interactive voice response survey (IVRS) and those assigned to paper diaries. Prior knowledge of biomarkers did not improve accuracy of self-reported condom or gel use, nor did it affect actual adherence. Of those who tested positive for the presence of semenogelin in the vagina, 76% reported no unprotected sex in the previous 48 h. Overall, women reported using gel on 90% of days whereas the biomarker indicated gel use on fewer than 50% of days. Compliance to IVRS was low, despite familiarity with mobile phone technology. Additional explorations with other populations are needed

Use of the dye stain assay and ultraviolet light test for assessing vaginal insertion of placebo-filled applicators before and after sex

Background: Applicator dye staining and ultraviolet (UV) light have been used in trials to measure adherence, but not in the setting of before and after sex gel dosing (BAT-24). This study was designed to determine if semen or presex gel dosing impacts the sensitivity and specificity of a dye stain assay (DSA) for measuring vaginal insertion of placebo-filled applicators with BAT-24 dosing. Methods: Healthy monogamous couples received Microlax-type applicators (Tectubes, Åstorp, Sweden) filled with hydroxyethylcelluose placebo gel. Women were instructed to vaginally insert 1 dose of gel before and a second dose after sex and to return applicators within 48 hours after sex. Applicators were stained to detect semen, followed by UV then DSA, and scored by 2 readers. Positive and negative controls were randomly included in applicator batches. Results: Fifteen couples completed the study. Each woman returned at least 6 applicators over a 30-day period. The sensitivity for insertion of postsex applicators was higher for UV (97%) compared with DSA (90%), and the specificity was similar ( ≥ 96%). For presex applicators, the sensitivity and specificity were higher for DSA (100%) compared with UV testing (87% sensitivity, 96% specificity). Among returned postsex applicators, 95% tested positive by UV compared with 87% by DSA. Agreement between readers was significantly better on the presex applicators for DSA than for UV, and for postsex readings, agreement was less than half that for UV, although the results were not statistically significant. Conclusions: Applicator tests are feasible for measuring adherence in trials with gel dosing before and after sex

Sexually Transmitted Infections and Reproductive Health Morbidity in a Cohort of Female Sex Workers Screened for a Microbicide Feasibility Study in Nellore, India

Short Summary: Four-month placebo vaginal gel trial conducted to determine the feasibility of recruiting FSWs for future Phase 2/3 microbicide trials. RH morbidity and HIV and STI prevalence are reported. Women constitute 38 % of India’s 2.4 million HIV-infected persons. Microbicides are potential HIV-prevention products currently undergoing clinical trials for efficacy. A four-month placebo vaginal gel trial was conducted in Nellore, India to determine the feasibility of recruiting a suitable cohort of female sex workers (FSWs) for a future vaginal microbicide efficacy trial. We report on the HIV and STI prevalence and reproductive health (RH) morbidity of FSWs screened for the trial. Results: 529 FSWs completed screening procedures; of those 33.6% were found ineligible. The mean age was 30.9 years; 68.6 % women were married and 57.5 % were home-based FSWs. Self-reported symptoms included abnormal vaginal discharge (31.6%), genital itching (3.4%), uterine mass/prolapse (3%) and painful intercourse (2.6%). Gynecological surgery was reported by 73.2 % of participants; of those 10.5 % had undergone a hysterectomy. Female sterilization was the most commonly reported contraceptive method. Pelvic examination showed vaginal discharge (50.7%), cervical discharge (5.3%), uterine/vaginal wall prolapse (2.6%), and cervical mass/nodule/vesicles/genital warts (4.2%). Common epithelia

Evaluation of 3 approaches for assessing adherence to vaginal gel application in clinical trials

Background: Accurate measurement of adherence to product use is an ongoing challenge in microbicide trials. Methods: We compared adherence estimates using 2 applicator tests (a dye stain assay [DSA] and an ultraviolet light assay [UVA]), the Wisebag (an applicator container that electronically tracks container openings), and self-reported adherence (ability, frequency, and percent missed doses). Healthy, HIV-negative, nonpregnant US women aged 23 to 45 years received a Wisebag and 32 applicators filled with placebo gel were instructed to insert 1 applicator daily for 30 days, returned the Wisebag and all applicators, and completed an exit interview. Emptied applicators were tested by UVA and then DSA, and scored by 2 blinded readers. Positive and negative controls were randomly included in applicator batches. Results: Among 42 women enrolled, 39 completed the study. Both DSA and UVA yielded similar sensitivity (97% and 95%) and specificity (79% and 79%). Two participants had fully inoperable Wisebags, and 9 had partially inoperable Wisebags. The proportion of participants considered to have high adherence ( ≥ 80%) varied: 43% (Wisebag), 46% (UVA), 49% (DSA), and 62% to 82% (self-reports). For estimating high adherence, Wisebag had a sensitivity of 76% (95% confidence interval, 50%–93%) and a specificity of 85% (95% confidence interval, 62%–97%) compared with DSA. Although 28% of participants reported forgetting to open the Wisebag daily, 59% said that it helped them remember gel use. Conclusions: Dye stain assay and UVA performed similarly. Compared with these tests, self-reports overestimated and Wisebag underestimated adherence. Although Wisebag may encourage gel use, the applicator tests currently seem more useful for measuring use in clinical trials