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

Abstract

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.

Perspectives from Young South African and Zimbabwean Women on Attributes of Four (Placebo) Vaginal Microbicide Delivery Forms

“…In previous studies assessing acceptability of potential intravaginal methods for HIV prevention, including diaphragms, gels, and rings, women's opinions have generally been very positive, particularly when measured quantitatively [8,[19][20][21][22]. Here, we found that women reported liking all the products, with the film more highly rated in Zimbabwe.…”

HIV Risk Characteristics Associated with Violence Against Women: A Longitudinal Study Among Women in the United States

“…[49][50][51][52] Despite mixed efficacy findings for products such as tenofovir gel 53,54 and the Phase III randomized placebocontrolled FEM-PrEP clinical trial of a daily oral dose of tenofovir disoproxil fumarate and emtricitabine, 55 microbicides may offer additional HIV prevention options for women with strong acceptability. [56][57][58] Yet, there remains a challenge to educate and offer PrEP to women experiencing violence.…”

Qualitative exploration of intrinsic and extrinsic factors that influence acceptability of semisoft vaginal suppositories

“…Other work suggests product features may also affect adherence. For gels, excessive leakage was a frequent complaint, leading women to not insert the full recommended dosage [ 14 ]. Some women questioned whether this leakage would reduce efficacy [ 15 ].…”