Acceptability Assessment in HIV Prevention and Treatment Intervention and Service Delivery Research: A Systematic Review and Qualitative Analysis.

We reviewed the literature on the assessment of acceptability of HIV prevention and treatment interventions and service delivery strategies. Following PRISMA guidelines, we screened 601 studies published from 2015 to 2020 and included 217 in our review. Of 384 excluded studies, 21% were excluded because they relied on retention as the sole acceptability indicator. Of 217 included studies, only 16% were rated at our highest tier of methodological rigor. Operational definitions of acceptability varied widely and failed to comprehensively represent the suggested constructs in current acceptability frameworks. Overall, 25 studies used formal quantitative assessments (including four adapted measures used in prior studies) and six incorporated frameworks of acceptability. Findings suggest acceptability assessment in recent HIV intervention and service delivery research lacks harmonization and rigor. We offer guidelines for best practices and future research, which are timely and critical in this era of informed choice and novel options for HIV prevention and treatment.

Vaginal ring acceptability and related preferences among women in low- and middle-income countries: A systematic review and narrative synthesis.

The vaginal ring (VR) is a female-initiated drug-delivery platform used for different indications, including HIV pre-exposure prophylaxis (PrEP). We conducted a systematic review of VR acceptability, values and preferences among women in low- and middle-income countries (LMIC) to inform further investment and/or guidance on VR use for HIV prevention. Following PRISMA guidelines, we used structured methods to search, screen, and extract data from randomized controlled trials (RCTs) and observational studies reporting quantitative outcomes of acceptability of the VR for any indication published 1/1970-2/2019 (PROSPERO: CRD42019122220). Of 1,110 records identified, 68 met inclusion criteria. Studies included women 15-50+ years from 25 LMIC for indications including HIV prevention, contraception, abnormal bleeding, and menopause. Overall VR acceptability was high (71-98% across RCTs; 62-100% across observational studies), with 80-100% continuation rates in RCTs and favorable ease of insertion (greater than 85%) and removal 89-99%). Users reported concerns about the VR getting lost in the body (8-43%), although actual expulsions and adverse events were generally infrequent. Most women disclosed use to partners, with some worrying about partner anger/violence. The VR was not felt during intercourse by 70-92% of users and 48-97% of partners. Acceptability improved over time both within studies (as women gained VR experience and worries diminished), and over chronological time (as the device was popularized). Women expressed preferences for accessible, long-acting, partner-approved methods that prevent both HIV and pregnancy, can be used without partner knowledge, and have no impact on sex and few side effects. This review was limited by a lack of standardization of acceptability measures and study heterogeneity. This systematic review suggests that most LMIC women users have a positive view of the VR that increases with familiarity of use; and, that many would consider the VR an acceptable future delivery device for HIV prevention or other indications.

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.

Preference between precoital and daily use of Duet® and BufferGel in Zimbabwe.

Duet® is a microbicide-delivery system and cervical barrier for use daily or precoitally. We conducted a crossover study among 80 Zimbabwean women to explore factors associated with use-regimen preference. Women were assigned in random order to 14 days of precoital and 14 days of daily Duet and BufferGel use. About 51 % of women preferred precoital use, 39 % preferred daily use, and 10 % liked both equally. Overall product adherence during sex was similar for both use-regimens. In multivariable analysis, diaphragm experience was associated with preference for precoital use (AOR 2.80, 95 % CI 1.01-7.76). Reasons for preferring precoital use included use only when needed, cleanliness, and discomfort with daily use. Daily use preference included convenience, discreetness, and being prepared for "sex-on-demand." Different personal and life circumstances may result in varying use-regimen preferences. Methods that can accommodate both coitally-related and daily use may be advantageous by providing more choice to users.

Bridewealth and sexual and reproductive practices among women in Harare, Zimbabwe.

This paper examines the relationship between bridewealth, socio-demographics, and sexual and reproductive practices among a group of women in Harare, Zimbabwe. The study sample was recruited as part of a six-month safety trial of the diaphragm and a microbicide, between August 2004 and April 2005 in Harare, Zimbabwe. Women underwent two screening visits: first, women completed a demographic and behavioral interviewer-administered questionnaire which included questions on bridewealth; at the second visit, women were offered HIV testing and counseling. Our results included: 417 women were married (currently or in the past) and almost half had had bridewealth negotiated as part of the marriage process. In multivariate analyses, women who were married with bridewealth had more years of education (OR 1.17, 95%CI 1.03-1.32), a higher age of coital debut (OR 1.37, 95%CI 1.09-1.71), and increased likelihood of having ever used male condoms (OR 1.54, 95%CI 1.01-2.37) compared with women who had been married without bridewealth. Bridewealth may be a relevant area of traditional culture to further examine in relation to HIV risk, for its potential association with co-factors that can reduce risk of HIV infection among women in Southern Africa.

"Come back when you're dying:" the commodification of AIDS among California's urban poor.

As with any other long-term illness, the decline in health that accompanies symptomatic HIV infection often has a profound negative impact on employment and personal finances. However, research to date on the financial consequences of AIDS has focused largely on middle-class working individuals, and cannot account for the experiences of those who are already poor and unemployed at the time of their infection. We conducted in-depth qualitative interviews with 33 Californian heterosexual couples in which one partner was infected with HIV and the other was HIV-negative. Most couples interviewed were low-income, marginally housed, and either former or active substance users. Unlike their middle-class counterparts, it became clear through the course of our study that many participating couples were living in a world in which a positive HIV antibody test or an AIDS diagnosis could result in an improved quality of life by allowing for increased access to Supplemental Security Income, subsidized housing, food and services. This situation is in part a consequence of recent policy decisions related to the "War on Drugs" and welfare reform. These policies have contributed to the creation of an economy of poverty in which the sick, needy, and addicted must compete against each other for scarce resources. Within such an economy, an HIV or AIDS diagnosis may actually operate as a commodity.