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Long-acting injectable antiretroviral treatment (LAI ART), such as a bimonthly injection of cabotegravir/rilpivirine, is a promising HIV treatment option. LAI ART may particularly benefit people who are reluctant to initiate or are poorly adherent to daily oral pills and not virally suppressed. However, the acceptability and feasibility of LAI ART among individuals with viremia in Africa has not been well studied. We conducted qualitative in-depth interviews with 38 people living with HIV with viral load ≥1000 copies/mL and 15 medical and nursing staff, and 6 focus group discussions with peer health workers, to examine acceptability and feasibility of LAI ART in south-central Uganda. Transcripts were thematically analyzed through a team-based framework approach. Most people living with HIV reacted positively toward LAI ART and endorsed interest in taking it themselves. Most felt LAI ART would make adherence easier by reducing the challenge with remembering daily pills, particularly in the context of busy schedules, travel, alcohol use, and dietary requirements. Participants also appreciated the privacy of injections, reducing the likelihood of stigma or inadvertent HIV serostatus disclosure with pill possession. Concerns about LAI ART included side effects, perceived medication effectiveness, fear of injection, and medical mistrust and conspiracy beliefs. Health workers and participants with viremia also noted health system challenges, such as stockouts and monitoring treatment failure. However, they felt the health system could overcome these challenges. Implementation complexities must be addressed as LAI ART is introduced and expanded in Africa to best support viral suppression and address HIV care continuum gaps.

It is unclear whether ongoing CD4 monitoring is needed following immunologic and virologic response to antiretroviral therapy (ART). We investigated the proportion of clients who achieved a virologic and immunologic response and then had a subsequent CD4 count <200 cells/μL despite continued virologic suppression. Included in this analysis were clients receiving ART through the Rakai Health Sciences Program between June 2004-May 2013 who achieved a CD4 ≥200 cells/μL and VL ≤400 copies/mL and who had three sets of CD4 and VL measurements (defined as a sequence) within a 390 day period. A CD4 decline was defined as any drop in CD4 count to <200 cells/μL during a period of viral suppression. A total of 1553 clients were included, 68% females, mean age of 35.5 years (SD 8.3), median baseline CD4 count 183 cells/μL (IQR 106-224). 43 (2.8%) clients developed CD4 declines, the majority, 32/43 (74%), among individuals whose initial CD4 was <300 cells/μL. Of the 43 clients with CD4 declines, 24 had an additional CD4 measurement and 20/24 (83%) achieved a CD4 ≥200 cell/μL on their next measurement (median 285 cells/μL; IQR 220-365). CD4 declines were significantly greater among those with lower CD4 at sequence initiation [adjusted hazard ratio (AHR) 4.3 (95% CI 2.1, 9.0) CD4 200-249 versus ≥350 cells/μL]. Clients who achieved an immunologic and virologic response to ART were unlikely to experience a subsequent CD4 count decline to <200 cells/μL, and among those experiencing a decline, the majority were transient in nature. Thus, ongoing CD4 monitoring could be omitted.

Settings with limited health care workers are challenging environments for delivery of antiretroviral therapy. One strategy to address this human resource crisis is to task shift through training selected patients as peer health workers (PHWs) to provide care to other individuals receiving antiretroviral therapy. To better understand processes of a cluster-randomized trial on the effect of these PHWs on AIDS care, we conducted a mixed methods operations research evaluation. Qualitative methods involved patients, PHWs, and clinic staff and included 38 in-depth interviews, 8 focus group discussions, and 11 direct observations. Quantitative methods included staff surveys, process, and virologic data analyses. Results showed that task shifting to PHWs positively affected structural and programmatic functions of care delivery--improving clinical organization, medical care access, and patient-provider communication--with little evidence for problems with confidentiality and inadvertent disclosure. Additionally, this evaluation elucidated trial processes including evidence for direct and indirect control arm contamination and evidence for mitigation of antiretroviral treatment fatigue by PHWs. Our results support the use of PHWs to complement conventional clinical staff in delivering AIDS care in low-resource settings and highlight how mixed methods operations research evaluations can provide important insights into community-based trials.