“Tell Juliana”: Acceptability of the Candidate Microbicide VivaGel® and Two Placebo Gels Among Ethnically Diverse, Sexually Active Young Women Participating in a Phase 1 Microbicide Study

Carballo‐Diéguez, Alex; Giguere, Rebecca; Dolezal, Curtis; Chen, Beatrice A.; Kahn, Jessica A.; Zimet, Gregory D.; Mabragaña, Marina; Leu, Cheng-Shiun; McGowan, Ian

doi:10.1007/s10461-011-0028-6

Cited by 39 publications

(34 citation statements)

References 19 publications

(21 reference statements)

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“…Nevertheless, feelings of runniness and leakage may be exacerbated in pregnant women experiencing increased vaginal discharge, highlighting the importance of studying special populations. Gel leakage and excess lubrication have been reported as a concern by men and women in other microbicide studies [19, 20], and while some have reportedly favored added lubrication, others have disliked how extra “wetness” changes the feeling of sex or reveals gel usage to partners. In this study, many women inserted gel in the morning, whereas in other studies such as VOICE, insertion at night was common [16].…”

Section: Discussionmentioning

confidence: 99%

Acceptability of and Adherence to an Antiretroviral-Based Vaginal Microbicide among Pregnant Women in the United States

et al. 2017

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The MTN-008 trial was the first multi-dose study conducted to evaluate the safety of a microbicide gel (2:1 randomized to tenofovir 1% or hydroxycellulose (HEC) placebo gel) during pregnancy. The study aim was to evaluate safety, tolerability and pharmacokinetics of the study products. Procedures included daily gel administration, with Day 0 and Day 6 in clinic, and Days 1–5 at home. Because pregnancy may pose unique challenges to consistent gel use and acceptability, evaluation of adherence and acceptability was a secondary objective of the trial. The study enrolled healthy, HIV-negative, pregnant women aged 18–40 in Pittsburgh, PA and Birmingham, AL, USA in 2 consecutive groups: cohort 1 was 37–39 weeks gestation, cohort 2 was 34–36 weeks. Ninety-one women completed the study (45 and 46 in each cohort, respectively) and were evaluable per protocol. Adherence was evaluated using self-reports: participants completed a web-based computer-assisted self-interview (CASI) at Days 0 and 6 about gel attitudes and behaviors. At Day 6 trained research staff conducted a short interviewer-administered questionnaire with both structured and open-ended questions. Frequencies of quantitative data were tabulated in SAS and descriptive statistics are presented; open-ended textual data were summarized by a behavioral scientist experienced in qualitative analysis. Participants reported generally neutral perceptions of gel characteristics. A small number of women (7–8%) reported pain (6/90), other physical discomfort (7/90), or mental discomfort (7/90) associated with the process of applicator insertion. About 5% reported the same for the gel itself. Two-thirds (61/90) thought the gel was runny, many complained of bothersome gel leakage and several cited this reason for not inserting a full dose. The majority were not worried the gel would cause problems for their pregnancy or babies. Ninety-seven percent (83/86) said they would use the gel in the future if they were pregnant, and 90% (81/90) when nonpregnant. Self-reported adherence was high with 88% (79/90) reporting daily gel use on both the computerized and interviewer-administered questionnaires. The majority (67/90) reported no difficulty with daily use. However, drug was undetectable (<0.31 ng/mL) among 45% (27/60; 95% CI 32–58%) of the women on active product prior to observed dosing at Day 6. The most common reason for reported nonuse (N = 6) was forgetting. Study gel was generally acceptable, but many complained of a runny consistency (61/90) and leakage (83/90). No frequent or strong concerns about the effects of the study gel on the pregnancy/fetus were reported. Self-reported adherence to study gel self-administered at home for 5 days was high, however plasma drug levels suggest actual use may have been considerably lower. Findings from this study can provide insights relevant to use of other antiretroviral-based, vaginally-inserted HIV prevention methods during pregnancy.

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Section: Discussionmentioning

confidence: 99%

Acceptability of and Adherence to an Antiretroviral-Based Vaginal Microbicide among Pregnant Women in the United States

et al. 2017

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“…The possibility of leakage and attendant need for panty liners has been a problem for non-pregnant women in microbicide studies 43 . Most of the women in this study regarded it as a surmountable barrier given that panty liner use is common during pregnancy; educating women to expect the leakage will still be important.…”

Section: Discussionmentioning

confidence: 99%

Attitudes towards microbicide use for bacterial vaginosis in pregnancy

et al. 2014

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Objectives Bacterial vaginosis (BV) is the most common reproductive tract infection (RTI) and is a significant risk factor for preterm birth. Microbicides could be an option for prevention and treatment of BV in pregnancy and understanding use of the product will be crucial to its success. The present study explored attitudes of women in the third trimester of pregnancy regarding topical microbicide use for prevention and treatment of BV. Methods Twenty-six women in their third trimester were interviewed regarding their knowledge and beliefs about RTIs during pregnancy and attitudes concerning the use of topical microbicides for prevention and treatment of BV. Results Participants had a mean age of 24.9 years, were largely underrepresented minorities and the majority had past pregnancies. Participants had knowledge and experience with RTIs but not BV. They were open to the use of microbicides for either prevention or treatment of BV, but believed that women requiring treatment would be more motivated. Rationales for acceptability were most commonly related to the baby's health. Practical issues that may interfere with use were often, but not always, related to pregnancy. There was a range of attitudes about partner involvement in decision-making and the practicalities of product use. Conclusion Pregnant women are knowledgeable about RTIs but not necessarily BV. The women in this study found microbicide use acceptable, particularly for treatment. To improve acceptability and use, education would be needed about BV and possible complications, how to overcome practical problems, and the value of involving partners in the decision.

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“…12,33 As microbicide clinical and safety trials continue, concurrent product acceptability research that incorporates multiple product dimension levels should be pursued, especially work aimed at clarifying these distinctions among adolescents and young adults. 13,15,34 …”

Section: Discussionmentioning

confidence: 99%

Young Women's Contraceptive Microbicide Preferences: Associations with Contraceptive Behavior and Sexual Relationship Characteristics

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Hensel

et al. 2013

Perspect Sexual Reproductive

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CONTEXT In time, microbicides may provide women with dual prevention against pregnancy and STDs. Although several microbicide dimensions have been evaluated, little is known about women's preferences for contraceptive microbicides and correlates of these preferences. METHODS Acceptability of a hypothetical contraceptive microbicide cream or jelly was examined among a clinic-based sample of 266 women in Indianapolis from 2004 (when participants were aged 14–22) to 2008. Group conjoint analyses and individual conjoint analyses were used to compare preferences with respect to four microbicide dimensions: contraceptive ability, efficacy in relation to condoms, timing of use and texture. Pearson's product moment correlations were used to examine the relationship between preferences for a contraceptive microbicide and selected characteristics of the women. RESULTS Overall, the top-rated microbicide dimensions were efficacy in relation to that of condoms and contraceptive ability (importance scores, 40.0 and 35.4 out of 100.0, respectively). When all dimension levels were compared, contraceptive ability was the most strongly preferred (part-worth utility score, 8.9), and lower efficacy than that of condoms was the least strongly preferred (– 11.9). Preference for contraceptive microbicides was positively associated with current contraceptive use, sexual agency, partner communication, commitment to avoiding pregnancy and perceived partner agreement about avoiding pregnancy (coefficients, 0.07– 0.18). It was negatively associated with current or past nonuse of contraceptives, seeking pregnancy and perceived partner agreement about seeking pregnancy (–0.08 to –0.14). CONCLUSIONS Microbicides with dual prevention properties may be attractive to young women. Microbicide development and subsequent clinical trials should incorporate contraceptive microbicides.

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“Tell Juliana”: Acceptability of the Candidate Microbicide VivaGel® and Two Placebo Gels Among Ethnically Diverse, Sexually Active Young Women Participating in a Phase 1 Microbicide Study

Cited by 39 publications

References 19 publications

Acceptability of and Adherence to an Antiretroviral-Based Vaginal Microbicide among Pregnant Women in the United States

Acceptability of and Adherence to an Antiretroviral-Based Vaginal Microbicide among Pregnant Women in the United States

Attitudes towards microbicide use for bacterial vaginosis in pregnancy

Young Women's Contraceptive Microbicide Preferences: Associations with Contraceptive Behavior and Sexual Relationship Characteristics

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