Suchergebnisse

AbstractIntroductionMajor depressive disorder, highly prevalent among people with HIV (PWH) globally, including South Africa, is associated with suboptimal adherence to antiretroviral therapy. Globally, there are insufficient numbers of mental health providers and tested depression treatments. This study's aim was to test task‐shared cognitive‐behavioural therapy for adherence and depression (CBT‐AD) in HIV, delivered by clinic nurses in South Africa.MethodsThis was a two‐arm randomized controlled effectiveness trial (recruitment: 14 July 2016 to 4 June 2019, last follow 9 June 2020). One‐hundred‐sixty‐one participants with clinical depression and virally uncontrolled HIV were recruited from primary care clinics providing HIV care, in Khayelitsha, South Africa. Arm 1 was task‐shared, nurse‐delivered CBT‐AD; and arm 2 was enhanced treatment as usual (ETAU). Primary outcomes (baseline to 4 months) were blinded Hamilton Depression Rating Scale (HAM‐D) scores, and weekly adherence via real‐time monitoring (Wisepill). Secondary outcomes were adherence and depression over 4‐, 8‐ and 12‐month follow‐ups, proportion of participants with undetectable viremia and continuous CD4 cell counts at 12 months. Additional analyses involved viral load and CD4 over time.ResultsAt 4 months, the HAMD scores in the CBT‐AD condition improved by an estimated 4.88 points more (CI: –7.86, –1.87, p = 0.0016), and for weekly adherence, 1.61 percentage points more per week (CI: 0.64, 2.58, p = 0.001) than ETAU. Over follow‐ups, CBT‐AD had an estimated 5.63 lower HAMD scores (CI: –7.90, –3.36, p < 0.001) and 23.56 percentage points higher adherence (CI: 10.51, 34.21, p < 0.001) than ETAU. At 12 months, adjusted models indicated that the odds of having an undetectable viremia was 2.51 greater at 12 months (CI: 1.01, 6.66, p = 0.047), and 3.54 greater over all of the follow‐ups (aOR = 3.54, CI: 1.59, 20.50; p = 0.038) for those assigned CBT‐AD. CD4 was not significantly different between groups at 12 months or over time.ConclusionsTask‐shared, nurse‐delivered, CBT‐AD is effective in improving clinical depression, ART adherence and viral load for virally unsuppressed PWH. The strategy of reducing depression to allow patients with self‐care components of medical illness to benefit from adherence interventions is one to extend. Implementation science trials and analyses of cost‐effectiveness are needed to translate findings into clinical practice.Trial RegistrationClinicalTrials.gov Identifier: NCT02696824 https://clinicaltrials.gov/ct2/show/NCT02696824

AbstractIntroductionSouth Africa (SA) has the highest number of people living with HIV (PLWH) globally, and a significant burden of alcohol and other drug use (AOD). Although integrating AOD treatment into HIV care may improve antiretroviral therapy (ART) adherence, this is not typically routine practice in SA or other low‐resource settings. Identifying interventions that are feasible and acceptable for implementation is critical to improve HIV and AOD outcomes.MethodsA pilot randomized hybrid type 1 effectiveness‐implementation trial (N = 61) was conducted to evaluate the feasibility and acceptability of Khanya, a task‐shared, peer‐delivered behavioral intervention to improve ART adherence and reduce AOD in HIV care in SA. Khanya was compared to enhanced treatment as usual (ETAU), a facilitated referral to on‐site AOD treatment. Implementation outcomes, defined by Proctor's model, included feasibility, acceptability, appropriateness and fidelity. Primary pilot effectiveness outcomes were ART adherence at post‐treatment (three months) measured via real‐time electronic adherence monitoring, and AOD measured using biomarker and self‐report assessments over six months. Data collection was conducted from August 2018 to April 2020.Results and discussionNinety‐one percent of participants (n = 56) were retained at six months. The intervention was highly feasible, acceptable, appropriate and delivered with fidelity (>90% of components delivered as intended by the peer). There was a significant treatment‐by‐time interaction for ART adherence (estimate = −0.287 [95% CI = −0.507, −0.066]), revealing a 6.4 percentage point increase in ART adherence in Khanya, and a 22.3 percentage point decline in ETAU. Both groups evidenced significant reductions in alcohol use measured using phosphatidylethanol (PEth) (F(2,101) = 4.16, p = 0.01), significantly decreased likelihood of self‐reported moderate or severe AOD (F(2,104) = 7.02, p = 0.001), and significant declines in alcohol use quantity on the timeline follow‐back (F(2,102) = 21.53, p < 0.001). Among individuals using drugs and alcohol, there was a greater reduction in alcohol use quantity in Khanya compared to ETAU over six months (F(2,31) = 3.28, p = 0.05).ConclusionsResults of this pilot trial provide initial evidence of the feasibility and acceptability of the Khanya intervention for improving adherence in an underserved group at high risk for ongoing ART non‐adherence and HIV transmission. Implementation results suggest that peers may be a potential strategy to extend task‐sharing models for behavioral health in resource‐limited, global settings.