Impact of Male Partner Involvement on Women’s Adherence to the Dapivirine Vaginal Ring During a Phase III HIV Prevention Trial

Roberts, Sarah T.; Nair, Gonasagrie; Baeten, Jared M.; Palanee-Philips, Thesla; Schwartz, Katie; Reddy, Krishnaveni; Kabwigu, Samuel; Kiweewa, Flavia Matovu; Govender, Vaneshree; Gaffoor, Zakir; Singh, Nishanta; Siva, Samantha; Naidoo, Kalendri; Montgomery, Elizabeth T.; Team, Aspire Study

doi:10.1007/s10461-019-02707-1

Cited by 40 publications

(33 citation statements)

References 28 publications

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“…A stronger relationship between partner acceptability and adherence was observed among older participants. This trend is supported by other qualitative findings from ASPIRE, where partner perceptions were often cited as a prominent influencer of acceptability and adherence [ 12 ] as well as work that looked at the relationship between reported partner support and adherence in ASPIRE [ 20 ]. Importantly, perceived partner acceptability does not necessarily equate to partner support, highlighting the importance of exploring these relationships both quantitatively and qualitatively.…”

Section: Discussionsupporting

confidence: 73%

Acceptability of the Dapivirine Vaginal Ring for HIV-1 Prevention and Association with Adherence in a Phase III Trial

et al. 2021

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We evaluated the acceptability of the 25 mg dapivirine vaginal ring (DVR) as an HIV prevention intervention and its influence on DVR adherence in the MTN-020/ASPIRE phase III trial. Acceptability measures were captured using ACASI at month 3 and end of product use (median 24 months, IQR 15–30). Monthly returned rings were classified as nonadherent if dapivirine release rate was ≤ 0.9 mg/month. Associations between acceptability measures and nonadherence were estimated using Poisson regression models with robust standard errors. At month 3 (N = 2334), 88% reported DVR was comfortable, 80% were unaware of it during daily activities, and 74% never felt it during sex. At exit, 66% were ‘very likely’ to use DVR in the future. Acceptability was found to differ significantly by country across several measures including wearing the ring during sex, during menses, partner acceptability, impact on sexual pleasure and willingness to use the ring in the future. Risk of nonadherence at month 12 was elevated if DVR was felt during sex at month 3 (aRR 1.67, 95% CI 1.26, 2.23). Risk of nonadherence in the last year of study participation was elevated if, at exit, participants minded wearing during sex (aRR 2.08, 95% CI 1.52, 2.85), during menses (aRR 1.57, 95% CI 1.06, 2.32), reported a problematic change to the vaginal environment (aRR 1.57, 95% CI 1.12, 2.21), and were not “very likely” to use DVR in the future (aRR 1.31, 95% CI 1.02, 1.68). DVR acceptability was overall high yet varied by country. Addressing perceived ring interference with sex, menses, or problematic changes to the vaginal environment in future interventions could help improve adherence, as could embracing sex-positive messaging related to ring use and increased pleasure.Trial Registration ClinicalTrials.gov Identifier: NCT01617096.

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Section: Discussionsupporting

confidence: 73%

Acceptability of the Dapivirine Vaginal Ring for HIV-1 Prevention and Association with Adherence in a Phase III Trial

et al. 2021

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“…While ring removals were infrequent, several participants reported ring outages due to partner‐related concerns. Prior studies have highlighted the important role of male partners on ring use and acceptability [32‐34]. A few participants in each arm reported removing the ring during menses.…”

Section: Discussionmentioning

confidence: 99%

Phase 1 pharmacokinetics and safety study of extended duration dapivirine vaginal rings in the United States

et al. 2021

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Introduction Vaginal rings are a promising approach to provide a woman‐centred, long‐acting HIV prevention strategy. Prior trials of a 25 mg dapivirine (DPV) ring have shown a favourable safety profile and approximately 30% risk reduction of HIV‐1 infection. Extended duration rings replaced every three months may encourage user adherence, improve health service efficiency and reduce cost overall. We evaluated safety, pharmacokinetics, adherence and acceptability of two three‐month rings with different DPV dosages, compared with the monthly DPV ring. Methods From December 2017 to October 2018, MTN‐036/IPM‐047 enrolled 49 HIV‐negative participant in Birmingham, Alabama and San Francisco, California into a phase 1, randomized trial comparing two extended duration (three‐month) rings (100 or 200 mg DPV) to a monthly 25 mg DPV ring, each used over 13 weeks, with follow‐up completed in January 2019. Safety was assessed by recording adverse events (AEs). DPV concentrations were quantified in plasma, cervicovaginal fluid (CVF) and cervical tissue, at nominal timepoints. Geometric mean ratios (GMRs) relative to the comparator ring were estimated from a regression model. Results There were no differences in the proportion of participants with grade ≥2 genitourinary AEs or grade ≥3 AEs in the extended duration versus monthly ring arms ( p = 1.0). Plasma and CVF DPV concentrations were higher in the extended duration rings compared to the monthly ring. Plasma GMRs were 1.31 to 1.85 and 1.41 to 1.86 and CVF GMRs were 1.45 to 2.87 and 1.74 to 2.60 for the 100 and 200 mg ring respectively. Cervical tissue concentrations were consistently higher in the 200 mg ring (GMRs 2.36 to 3.97). The majority of participants (82%) were fully adherent (ring inserted at all times, with no product discontinuations/outages) with no differences between the monthly versus three‐month rings. Most participants found the ring acceptable (median = 8 on 10‐point Likert scale), with a greater proportion of participants reporting high acceptability (9 or 10) in the 25 mg arm (73%) compared with the 100 mg (25%) and 200 mg (44%) arms ( p = 0.01 and p = 0.15 respectively). Conclusions The extended duration DPV rings were well‐tolerated and achieved higher DPV concentrations compared with the monthly DPV ring. These findings support further evaluation of three‐month DPV rings for HIV prevention.

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“…Patients with HIV were supported not only in psychological well-being and financial status but also with medical care and daily activities. The significant correlation between partner support and adherence to ART was well documented; women were more likely to have low adherence if they had an unsupportive male partner [ 18 , 19 ].…”

Section: Discussionmentioning

confidence: 99%

Prevalence and Determinants of Medication Adherence among Patients with HIV/AIDS in Southern Vietnam

Nguyen

Thach

Pham

et al. 2021

Infectious Disease Reports

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This study was conducted to determine the prevalence and determinants of medication adherence among patients with HIV/AIDS in southern Vietnam. Methods: A cross-sectional study was conducted in a hospital in southern Vietnam from June to December 2019 on patients who began antiretroviral therapy (ART) for at least 6 months. Using a designed questionnaire, patients were considered adherent if they took correct medicines with right doses, on time and properly with food and beverage and had follow-up visits as scheduled. Multivariable logistic regression was used to identify determinants of adherence. Key findings: A total of 350 patients (from 861 medical records) were eligible for the study. The majority of patients were male (62.9%), and the dominant age group (≥35 years old) accounted for 53.7% of patients. Sexual intercourse was the primary route of transmission of HIV (95.1%). The proportions of participants who took the correct medicine and at a proper dose were 98.3% and 86.3%, respectively. In total, 94.9% of participants took medicine appropriately in combination with food and beverage, and 75.7% of participants were strictly adherent to ART. The factors marital status (odds ratio (OR) = 2.54; 95%CI = 1.51–4.28), being away from home (OR = 1.7; 95%CI = 1.03–2.78), substance abuse (OR = 2.7; 95%CI = 1.44–5.05), general knowledge about ART (OR = 2.75; 95%CI = 1.67–4.53), stopping medication after improvement (OR = 4.16; 95%CI = 2.29–7.56) and self-assessment of therapy adherence (OR = 9.83; 95%CI = 5.44–17.77) were significantly associated with patients’ adherence. Conclusions: Three-quarters of patients were adherent to ART. Researchers should consider these determinants of adherence in developing interventions in further studies.

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Impact of Male Partner Involvement on Women’s Adherence to the Dapivirine Vaginal Ring During a Phase III HIV Prevention Trial

Cited by 40 publications

References 28 publications

Acceptability of the Dapivirine Vaginal Ring for HIV-1 Prevention and Association with Adherence in a Phase III Trial

Acceptability of the Dapivirine Vaginal Ring for HIV-1 Prevention and Association with Adherence in a Phase III Trial

Phase 1 pharmacokinetics and safety study of extended duration dapivirine vaginal rings in the United States

Prevalence and Determinants of Medication Adherence among Patients with HIV/AIDS in Southern Vietnam

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