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Antiretroviral therapy (ART) is efficacious in improving clinical outcomes among people living with HIV (PLWH) and reducing HIV transmission when taken regularly. Research examining modifiable factors associated with ART non-adherence is critical for informing novel intervention development in settings with high HIV prevalence. Alcohol use has been linked with ART non-adherence in studies in sub-Saharan Africa; however, no review has pooled estimates across studies. We reviewed studies of alcohol use and ART non-adherence conducted in sub-Saharan Africa. We searched PubMed, CINAHL, EMBASE, and PsycINFO through August 2019 with terms related to ART non-adherence, alcohol use, and sub-Saharan Africa. One author reviewed titles/abstracts (n = 754) and two authors reviewed full texts (n = 308) for inclusion. Discrepancies were resolved by group consensus. Studies were retained if they quantitatively measured associations between alcohol use and ART non-adherence or viral non-suppression. We defined ART non-adherence using the definitions from each parent study (e.g., patients with > 5% missed ART doses during the previous four, seven or 30 days were considered non-adherent). A random effects meta-analysis was conducted to pool associations and we conducted additional analyses to assess between-study heterogeneity and publication bias and sensitivity analyses to determine robustness of our results when considering only certain study designs, alcohol use or ART scales, or studies that used viral non-suppression as their primary outcome. Of 56 articles meeting our inclusion criteria, 32 articles were included in the meta-analysis. All studies measured alcohol use via self-report. ART non-adherence was assessed using self-report, pill counts, or pharmacy records and definition of non-adherence varied depending on the measure used. Individuals who used alcohol had twice the odds of ART non-adherence compared with those who did not use alcohol (34% non-adherence among alcohol users vs. 18% among non-users; pooled odds ratio: 2.25; 95% confidence interval: 1.87–2.69; p < 0.001). We found evidence of a high degree of heterogeneity between studies (Cochrane Q statistic: 382.84, p< 0.001; I2 proportion: 91.9%) and evidence of publication bias. However, the magnitude of our pooled odds ratio was consistent across a number of sensitivity analyses to account for heterogeneity and publication bias. In a secondary analysis with studies using viral non-suppression as their primary outcome, we also estimated a statistically significant pooled effect of alcohol use on viral non-suppression (pooled odds ratio: 2.47; 95% confidence interval: 1.58–3.87). Evidence suggests alcohol use is associated with ART non-adherence in Sub-Saharan Africa, potentially hindering achievement of the UNAIDS 90-90-90 HIV treatment targets.

Medication adherence plays an important role in optimizing the outcomes of many treatment and preventive regimens in chronic illness. Self-report is the most common method for assessing adherence behavior in research and clinical care, but there are questions about its validity and precision. The NIH Adherence Network assembled a panel of adherence research experts working across various chronic illnesses to review self-report medication adherence measures and research on their validity. Self-report medication adherence measures vary substantially in their question phrasing, recall periods, and response items. Self-reports tend to overestimate adherence behavior compared with other assessment methods and generally have high specificity but low sensitivity. Most evidence indicates that self-report adherence measures show moderate correspondence to other adherence measures and can significantly predict clinical outcomes. The quality of self-report adherence measures may be enhanced through efforts to use validated scales, assess the proper construct, improve estimation, facilitate recall, reduce social desirability bias, and employ technologic delivery. Self-report medication adherence measures can provide actionable information despite their limitations. They are preferred when speed, efficiency, and low-cost measures are required, as is often the case in clinical care.

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.

Background In 2020, 14% of diagnosed persons living with HIV (PLWH) in Kenya were not taking antiretroviral therapy (ART), and 19% of those on ART had unsuppressed viral loads. Long-acting antiretroviral therapy (LA-ART) may increase viral suppression by promoting ART uptake and adherence. We conducted key informant (KI) interviews with HIV experts in Kenya to identify product and delivery attributes related to the acceptability and feasibility of providing LA-ART to PLWH in Kenya. Methods Interviews were conducted via Zoom on potential LA-ART options including intra-muscular (IM) injections, subcutaneous (SC) injections, implants, and LA oral pills. KI were asked to discuss the products they were most and least excited about, as well as barriers and facilitators to LA-ART roll-out. In addition, they were asked about potential delivery locations for LA-ART products such as homes, pharmacies, and clinics. Interviews were recorded and transcribed, and data were analyzed using a combination of inductive and deductive coding. Results Twelve KI (5 women, 7 men) participated between December 2021 and February 2022. Overall, participants reported that LA-ART would be acceptable and preferable to PLWH because of fatigue with daily oral pills. They viewed IM injections and LA oral pills as the most exciting options to ease pill burden and improve adherence. KI felt that populations who could benefit most were adolescents in boarding schools and stigmatized populations such as sex workers. SC injections and implants were less favored, as they would require new training initiatives for patients or healthcare workers on administration. In addition, SC injections would require refrigeration and needle disposal after use. Some KI thought patients, especially men, might worry that IM injections and implants would impact fertility, given their role in family planning. Pharmacies were perceived by most KI as suboptimal delivery locations; however, given ongoing work in Kenya to include pharmacies in antiretroviral delivery, they recommended asking patients their views. Conclusion There is interest and support for LA-ART in Kenya, especially IM injections and LA oral pills. Identifying patient preferences for modes and delivery locations and addressing misconceptions about specific products as they become available will be important before wide-scale implementation.

Excessive alcohol intake has been associated with poor adherence to antiretroviral therapy (ART). The impact of alcohol on viral suppression is particularly important among groups at high risk of HIV transmission, such as female sex workers (FSWs). Few studies have directly evaluated the association between alcohol use and HIV viral load. We hypothesized that hazardous or harmful alcohol use is associated with detectable plasma viral load among HIV-positive FSWs. A prospective cohort study was conducted among HIV-positive FSWs in Mombasa, Kenya. Hazardous or harmful alcohol use was assessed yearly and defined as an Alcohol Use Disorders Identification Test (AUDIT) score ≥7. Detectable viral load was assessed every six months and defined as ≥180 c/mL. Adherence measures were collected monthly and included late ART refill (>48 hours) and self-reported adherence, using both a validated self-rating scale of ability to take medication and visual analog scale (VAS) of ART use in the last month. Generalized estimating equations were used to estimate adjusted relative risks (aRR) and 95% confidence intervals (CI). This analysis included 366 participants followed monthly between October 2012 and March 2018. At baseline, AUDIT scores indicated hazardous alcohol use (AUDIT 7-15) in 14.3%, harmful alcohol use (AUDIT 16-19) in 1.4%, and alcohol dependency (AUDIT ≥20) in 1.4% of participants. After adjusting for potential confounders, a combined exposure including hazardous, harmful, and dependent alcohol use was not associated with detectable viral load (aRR 1.10, 95%CI 0.63-1.92) or late ART refill (aRR 1.13, 95%CI 0.82-1.56), but was associated with lower self-rated ability to take medication (aRR 2.38, 95%CI 1.42-3.99) and a lower rate of self-reported perfect ART adherence by VAS (aRR 2.62, 95%CI 1.84-3.71). In this FSW cohort, while participants reporting hazardous, harmful, or dependent alcohol use were not more likely to have a detectable viral load, they were more likely to report lower ART adherence. These results suggest that interventions targeting alcohol use among this population of FSWs may not have a large impact on viral suppression.

Behavioral interventions that promote adherence to antiretroviral medications may decrease HIV treatment failure. Antiretroviral treatment programs in sub-Saharan Africa confront increasing financial constraints to provide comprehensive HIV care, which include adherence interventions. This study compared the impact of counseling and use of an alarm device on adherence and biological outcomes in a resource-limited setting. A randomized controlled, factorial designed trial was conducted in Nairobi, Kenya. Antiretroviral-naïve individuals initiating free highly active antiretroviral therapy (HAART) in the form of fixed-dose combination pills (d4T, 3TC, and nevirapine) were randomized to one of four arms: counseling (three counseling sessions around HAART initiation), alarm (pocket electronic pill reminder carried for 6 months), counseling plus alarm, and neither counseling nor alarm. Participants were followed for 18 months after HAART initiation. Primary study endpoints included plasma HIV-1 RNA and CD4 count every 6 months, mortality, and adherence measured by monthly pill count. Between May 2006 and September 2008, 400 individuals were enrolled, 362 initiated HAART, and 310 completed follow-up. Participants who received counseling were 29% less likely to have monthly adherence <80% (hazard ratio [HR] = 0.71; 95% confidence interval [CI] 0.49-1.01; p = 0.055) and 59% less likely to experience viral failure (HIV-1 RNA ≥5,000 copies/ml) (HR 0.41; 95% CI 0.21-0.81; p = 0.01) compared to those who received no counseling. There was no significant impact of using an alarm on poor adherence (HR 0.93; 95% CI 0.65-1.32; p = 0.7) or viral failure (HR 0.99; 95% CI 0.53-1.84; p = 1.0) compared to those who did not use an alarm. Neither counseling nor alarm was significantly associated with mortality or rate of immune reconstitution. Intensive early adherence counseling at HAART initiation resulted in sustained, significant impact on adherence and virologic treatment failure during 18-month follow-up, while use of an alarm device had no effect. As antiretroviral treatment clinics expand to meet an increasing demand for HIV care in sub-Saharan Africa, adherence counseling should be implemented to decrease the development of treatment failure and spread of resistant HIV.

Following male circumcision for HIV prevention, a high proportion of men fail to return for their scheduled seven-day post-operative visit. We evaluated the effect of short message service (SMS) text messages on attendance at this important visit. We enrolled 1200 participants >18 years old in a two-arm, parallel, randomized controlled trial at 12 sites in Nyanza province, Kenya. Participants received daily SMS text messages for seven days (n = 600) or usual care (n = 600). The primary outcome was attendance at the scheduled seven-day post-operative visit. The primary analysis was by intention-to-treat. Of participants receiving SMS, 387/592 (65.4%) returned, compared to 356/596 (59.7%) in the control group (relative risk [RR] = 1.09, 95% confidence interval [CI] 1.00-1.20; p = 0.04). Men who paid more than US$1.25 to travel to clinic were at higher risk for failure to return compared to those who spent ≤ US$1.25 (adjusted relative risk [aRR] 1.35, 95% CI 1.15-1.58; p<0.001). Men with secondary or higher education had a lower risk of failure to return compared to those with primary or less education (aRR 0.87, 95% CI 0.74-1.01; p = 0.07). Text messaging resulted in a modest improvement in attendance at the 7-day post-operative clinic visit following adult male circumcision. Factors associated with failure to return were mainly structural, and included transportation costs and low educational level. ClinicalTrials.govNCT01186575.

Background For people with HIV (PWH), long-acting antiretroviral therapies (LA-ART) are promising treatment alternatives to daily oral regimens, with potential to improve adherence and achieve viral suppression. Understanding patient preferences is crucial for successful and efficient implementation and scaling of LA-ART in resource-limited settings such as Kenya. We conducted a discrete choice experiment (DCE) to elicit preferences for LA-ART attributes among PWH in Kenya. Methods We recruited 700 PWH taking daily oral ART from Kenyatta National Hospital and two Sex Workers Outreach Program clinics in Nairobi. In 17 choice scenarios, participants chose between their current daily oral regimen and two hypothetical LA-ART alternatives defined by seven attributes: delivery mode (long-acting oral, subcutaneous or intramuscular injection, implant), administration location (clinic, chemist, home), frequency (weekly, every 1, 2, 3, 6, or 12 months), delivery-site pain (none, mild, moderate), pre-treatment viral suppression (required, not required), pre-treatment negative reaction testing (required, not required), and late-dose leeway (short, long). We used conditional logistic regressions with interactions between mode and pain to determine the relative importance in participants’ choices across attributes. Results Participants had a median age of 36 years (interquartile range [IQR]: 28–46); 64% were female, 83% were virally suppressed, 51% were from key populations (e.g., sex workers or men who have sex with men), and median time on ART was 9 years (IQR: 5–15). Participants generally preferred the hypothetical LA-ART options over their current daily oral ART, and the interaction of delivery mode and pain was the most important attribute combination. Oral LA-ART was the most preferred mode; 1-year implants with mild pain was the next preferred option. Participants favored administration at clinics to chemists or home and preferred less frequent dosing. Conclusions LA-ART would be highly acceptable in Kenya, with oral LA-ART and administration at clinics as the preferred formulation and location. Our findings provide valuable evidence to guide the development of novel LA-ART products. Future research should evaluate preference heterogeneity and investigate ways to effectively scale LA-ART in Kenya and similar settings, while taking into account patient preferences. Clinical trial number Not applicable.

Background Long-acting antiretroviral therapy (LA-ART) is an emerging alternative to daily oral ART pills that may improve HIV treatment adherence. We studied preference heterogeneity for LA-ART among people with HIV (PWH) in western Washington State and Atlanta, Georgia to determine how preference heterogeneity was related to individual characteristics. Methods We recruited 699 PWH to complete a survey including 17 choice-tasks, each of which included two hypothetical LA-ART alternatives and current daily oral therapy. Each hypothetical alternative was defined by mode (long-acting [LA] oral pills, subcutaneous injections, intramuscular injections, and implants), frequency, treatment location (home, clinic, or pharmacy), injection pain, pre-treatment time undetectable, pre-treatment reaction testing, and late-dose leeway. We fitted a latent class model to the data and investigated associations between class membership and individual characteristics. Results Our sample had three classes which were defined by their treatment preferences. Two classes preferred LA-ART over current treatment: the LA-Implant class (29%) and the LA-Oral-or-Injection class (35%). In contrast, the Daily-or-LA-Oral class (36%) preferred current treatment or LA oral pills taken at home. Compared to the third class, participants from the other two were younger, more educated, less adherent to current ART, and less averse to injections. Further, LA-Implant participants were less likely to be virally suppressed and had easier clinic access. LA-Oral-or-Injection participants had a higher prevalence of psychotic disorders. Conclusion These results provide a deeper understanding of the preference landscape for LA-ART and can aid in the development of interventions better aligned with individual preferences.

Gay, bisexual, and other men who have sex with men (MSM) experience alarming HIV disparities alongside sub-optimal engagement in HIV interventions. Among MSM, stigma toward anal sexuality could interfere with engagement in HIV prevention, yet few studies have examined MSM perspectives on anal sex stigma or its health-related sequelae. Guided by theory, we aimed to characterize anal sex stigma, related sexual concerns, and barriers to health seeking, like concealment. We elicited community input by purposively interviewing 10 experts in MSM health and then 25 racially, ethnically, and geographically diverse cisgender MSM. Participants reported experienced, internalized, and anticipated forms of anal sex stigma that inhibited health seeking. Experienced stigma, including direct and observed experiences as well as the absence of sex education and information, contributed to internalized stigma and anticipation of future devaluation. This process produced psychological discomfort and concealment of health-related aspects of anal sexuality, even from potentially supportive sexual partners, social contacts, and health workers. Participants characterized stigma and discomfort with disclosure as normative, pervasive, and detrimental influences on health-seeking behavior both during sex and within healthcare interactions. Omission of information appears to be a particularly salient determinant of sexual behavior, inhibiting prevention of harm, like pain, and leading to adverse health outcomes. The development of measures of anal sex stigma and related sexual concerns, and testing their impact on comfort with disclosure, sexual practices, and engagement in health services could identify modifiable social pathways that contribute to health disparities among MSM, like those seen in the HIV epidemic.