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We conducted a parallel-group randomized controlled trial in three HIV clinics in Mexico to evaluate a user-centred habit-formation intervention to improve ART adherence among MSM living with HIV. We randomized 74 participants to the intervention group and 77 to the control group. We measured adherence at one, four, and ten months through medication possession ratio and self-reported adherence. Additionally, we measured viral load, CD4 cell count, major depression disorder symptoms, and alcohol and substance use disorder at baseline, fourth and tenth months. We found no statistically significant effect on adherence between groups. However, the intervention demonstrated positive results in major depression disorder symptoms (21% vs. 6%, p = 0.008) and substance use disorder (11% vs. 1%, p = 0.018) in the fourth month. The latter is relevant because, in addition to its direct benefit, it might also improve the chances of maintaining adequate adherence in the long term. This trial was retrospectively registered at ClinicalTrials.gov (trial number NCT03410680) on 8 January 2018. Trial registration: ClinicalTrials.gov identifier: NCT03410680. [ABSTRACT FROM AUTHOR]

Pain is common and associated with substance use among persons with HIV (PWH), yet limited management strategies exist. We assessed the feasibility, tolerability, and safety of low-dose naltrexone and standard dose nalmefene to treat chronic pain among PWH with past-year heavy alcohol use in a randomized, double-blinded, 2-arm study (planned enrollment 8 per arm). Participants were recruited in St. Petersburg, Russia between May and October 2018 and randomized to receive either nalmefene (16 mg) or low-dose naltrexone (4.5 mg) for 8 weeks. The primary outcome was tolerability of medication at eight weeks. Study visits included assessments of pain interference and severity, as well as cold-pressor testing. All participants in the nalmefene arm (N = 3) discontinued the study medication early due to side effects; nalmefene was subsequently deemed intolerable and this arm was terminated. The mean tolerability score at 8-weeks in the low-dose naltrexone arm was 90.7 (SD 22.44), median was 100 (IQR 95- 100), and median cold pain tolerance was approximately 10 s higher at the end of the 8 weeks. Low-dose naltrexone was well-tolerated, but nalmefene was not, in this sample. Further research is warranted to explore low-dose naltrexone's potential efficacy as a non-addictive treatment for pain in this population. ClinicalTrials.gov identifier: NCT03278886. [ABSTRACT FROM AUTHOR]

Adolescents and young adults (AYA) 13–24 years old make up a disproportionate 21% of new HIV diagnoses. Unfortunately, they are less likely to treat HIV effectively, with only 30% achieving viral suppression, limiting efforts to interrupt HIV transmission. Previous work with mindfulness-based stress reduction (MBSR) has shown promise for improving treatment in AYA living with HIV (AYALH). This randomized controlled trial compared MBSR with general health education (HT). Seventy-four 13–24-year-old AYALH conducted baseline data collection and were randomized to nine sessions of MBSR or HT. Data were collected at baseline, post-program (3 months), 6 and 12 months on mindfulness and HIV management [medication adherence (MA), HIV viral load (HIV VL), and CD4]. Longitudinal analyses were conducted. The MBSR arm reported higher mindfulness at baseline. Participants were average 20.5 years old, 92% non-Hispanic Black, 51% male, 46% female, and 3% transgender. Post-program, MBSR participants had greater increases than HT in MA (p = 0.001) and decreased HIV VL (p = 0.052). MBSR participants showed decreased mindfulness at follow-up. Given the significant challenges related to HIV treatment in AYALH, these findings suggest that MBSR may play a role in improving HIV MA and decreasing HIV VL. Additional research is merited to investigate MBSR further for this important population. [ABSTRACT FROM AUTHOR]

Achieving the 95-95-95 UNAIDS targets requires meeting the needs of adolescents, however we lack evidenced-based approaches to improving adolescent adherence to antiretroviral therapy (ART), increasing viral suppression, and supporting general wellbeing. We developed Family Connections as a group intervention for adolescents and their adult caregivers and conducted a randomized controlled trial in Ndola, Zambia to test feasibility and acceptability. Fifty pairs (n = 100) of adolescents (15–19 years and on ART ≥ 6 months) and their caregivers were randomly assigned either to the intervention consisting of 10 group sessions over 6 months, or to a comparison group, which received the usual care. Each pair completed baseline and endline surveys, with adolescents also undergoing viral load testing. Of the 24-intervention adolescent/caregiver pairs, 88% attended at least eight group sessions. Most adolescents (96%) and all caregivers would recommend Family Connections to peers. Adolescent viral failure decreased but did not significantly differ by study group. Adolescents in the intervention group showed a greater reduction in HIV-related feelings of worthlessness and shame than the comparison group. The feasibility, acceptability, and the positive trend toward significantly reducing internalized stigma, generated by this Family Connections pilot study, contributes valuable data to support adolescent/caregiver approaches that use peer groups. [ABSTRACT FROM AUTHOR]

In Mozambique, women are the most affected by HIV/AIDS and heterosexual encounters remain the main route for HIV/AIDS. Condom use is the most effective method of HIV/AIDS prevention, and the intention to use and buy/get condoms has a significant role in safe sex behavior. This study aimed to evaluate the efficacy of two psychosocial interventions – the Didactic and ACCENT Interventions – to prevent HIV/AIDS among Mozambican Women. Participants were Mozambican women (n = 150), users of the gynecology clinic of the Central Hospital of Beira. The study design was a randomized controlled trial (RCT) with assignment to three groups: Didactic intervention, ACCENT intervention, and Control group. Measures were from an adaption of the Women's Health Questionnaire, which includes questions about sociodemographic, clinical, and behavioral variables related to HIV prevention/risk. There was a significant group effect on condom use and safer sex preparatory behaviors, F(2, 146) = 6.45, p =.002, with Bonferroni post-hoc tests showing differences between the ACCENT vs. Control groups and ACCENT vs. Didactic groups (all p =.022). There were no statistically significant time effects on both condom use and safer sex preparatory behaviors. Results are promising for HIV/AIDS prevention in Mozambican women at sexual risk, but replication is needed for generalizability of findings. [ABSTRACT FROM AUTHOR]

Supporting Treatment Adherence Readiness through Training (START) is an HIV antiretroviral adherence intervention, based on the Information Motivation and Behavioral skills (IMB) model, that significantly improved adherence in our randomized controlled trial. To understand how and for whom START had its effects on adherence, we examined mediators and moderators. Ninety-nine HIV-patients (53 control, 46 intervention) who enrolled in the trial and provided month 6 electronic monitored adherence data. The intervention was associated with increased adherence-related knowledge and lower impulsive/careless problem solving, but had no effects on other IMB-related constructs. Neither of these variables mediated the adherence effects of the intervention (based on linear regression models with bootstraping for unbiased standard errors). Four variables interacted with the intervention to moderate its effects: the intervention group had consistent high adherence across the range of depression and time since HIV diagnosis, compared to lower adherence with higher values in the usual care control; those with unstable housing or frequent drug use had higher adherence if in the intervention group compared to the control group. These findings suggest that START provides support that enables its recipients to cope with and overcome challenges (e.g., depression, unstable housing, drug use) that would typically impede adherence. Trial registration: ClinicalTrials.gov identifier: NCT02329782. [ABSTRACT FROM AUTHOR]

This mixed methods study aimed to evaluate the feasibility and preliminary efficacy of a fully automated, interactive smartphone-delivered intervention for smoking cessation among people living with HIV in Cambodia. We used the explanatory sequential design, with a pilot two-group single-blind randomized controlled trial (N = 50) followed by in-depth interviews with all trial participants. In the trial, participants were randomized to Standard Care (SC) or Automated Messaging (AM) group. SC comprised brief advice to quit and self-help materials. AM consisted of the SC components plus a fully automated smartphone-based treatment program that involved interactive and tailored proactive messaging for 2 months. Results showed that the AM approach was highly feasible and efficacious. Feasibility was supported by high rates of treatment engagement (e.g., 81% of delivered messages and assessments were read or completed) and high retention (96%) through the 2-month follow-up. Biochemically verified point prevalence abstinence at follow-up was 40% for the AM group and 8% for the SC group (relative risk: 5.0, 95% confidence interval: 1.2, 20.5). Being able to avoid other smokers, having coping skills, and having social/familial support contributed to successful abstinence. The AM program has the potential for wide-scale implementation in Cambodia and other low-income countries. [ABSTRACT FROM AUTHOR]

Determine the feasibility, acceptability, and preliminary effectiveness of financial incentives to motivate re-engagement in HIV care in Shinyanga, Tanzania. Out-of-care people living with HIV (PLHIV) were identified from medical records in four clinics and home-based care providers (HBCs) from April 13, 2018 to March 3, 2020. Shinyanga Region residents, ≥18 years, who were disengaged from care were randomized 1:1 to a financial incentive (∼$10 USD) or the standard of care (SOC), stratified by site, and followed for 180 days. Primary outcomes were feasibility (located PLHIV who agreed to discuss the study), acceptability (enrollment among eligibles), and re-engagement in care (clinic visit within 90 days). HBCs located 469/1,309 (35.8%) out-of-care PLHIV. Of these, 215 (45.8%) were preliminarily determined to be disengaged from care, 201 (93.5%) agreed to discuss the study, and 157 eligible (100%) enrolled. Within 90 days, 71 (85.5%) PLHIV in the incentive arm re-engaged in care vs. 58 (78.4%) in the SOC (Adjusted Risk Difference [ARD] = 0.08, 95% CI: −0.03, 0.19, p = 0.09). A higher proportion of incentivized PLHIV completed an additional (unincentivized) visit between 90–180 days (79.5% vs. 71.6%, ARD = 0.10, 95% CI: −0.03, 0.24, p = 0.13) and remained in care at 180 days (57.8% vs. 51.4%, ARD = 0.07, 95% CI: −0.09, 0.22, p = 0.40). Short-term financial incentives are feasible, acceptable, and have the potential to encourage re-engagement in care, warranting further study of this approach. [ABSTRACT FROM AUTHOR]

Retention in care is a major challenge for global AIDS control, including sub-Saharan Africa. In a large Ethiopian region, we evaluated an intervention where HIV positive community support workers (CSWs) provided HIV health education, personal counseling and social support for HIV patients new to care. We enrolled 1,799 patients recently entering care from 32 hospitals and health centers, randomized to intervention or control sites. Dates of all clinic visits, plus deaths or transfers were abstracted from HIV medical records. Primary outcomes were gap in clinical care (>90 days from a missed clinical or drug pickup appointment) and death. For 36 months of follow-up, and for the first 12 months after enrollment, weighted risk differences [RD] between treatment arms were modest and non-significant for gap in clinical care, death or either outcome. Through 36 months, 624 of 980 controls and 469 of 819 intervention participants had gaps in clinical care (RD = −5.5%, 95% confidence interval [CI] = −17.9%, 7.0%); 79 controls and 82 intervention participants died (RD = 2.5% 95% CI = −1.7%, 6.8%). Factors including HIV stigma and a volatile political climate may have attenuated the advantages we anticipated, demonstrating how benefits of CSW interventions may depend upon psychosocial, clinical and structural factors particular to specific community settings. [ABSTRACT FROM AUTHOR]

HIV remains elevated among female sex workers (FSW) globally, with a number of structural (e.g., poverty, access to care) factors driving these persistently high rates. Pre-exposure prophylaxis (PrEP), a user-controlled prevention method, is a promising means of empowering vulnerable populations to protect themselves and enhance agency. Yet there is a dearth of PrEP research and interventions targeting cisgender women in the United States, and even fewer aimed to reach FSW. We developed and implemented a multifaceted PrEP pilot intervention, the Promoting Empowerment And Risk Reduction (PEARL) study, to meet this gap. This paper describes the development process and nature of a community-informed intervention for tenofovir/emticitrabine (TDF/FTC) pre-exposure prophylaxis engagement among street-based cisgender FSW in Baltimore, Maryland, U.S. In the course of the study's implementation, structural, programmatic, and medical barriers have already posed significant barriers to full engagement. PEARL implemented a number of strategies in an effort to counter barriers and facilitate increased success of PrEP uptake and maintenance. The study will provide critical insights into the nature of intervention components that could help FSW to initiate PrEP and reduce PrEP care cascade gaps. [ABSTRACT FROM AUTHOR]

Although exercise has been shown to improve cardiorespiratory and metabolic outcomes in people with HIV, its effect on cognitive ability remains understudied. Our study aimed to estimate the feasibility and efficacy potential of a 12-week aerobic and resistance training program on cognitive and physical performance outcomes. This is an externally controlled, two time-point, feasibility study within a larger study using a cohort multiple randomized controlled design yielding 3 groups: intervention group; comparison group and refusers. The intervention consisted of high-intensity interval training and resistance exercises 3 days/week. Specific feasibility and brain health outcomes were evaluated. Cognitive ability was ascertained by the Brief Cognitive Ability Measure (B-CAM) in all three groups. Standardized tests of physical performance were performed in the intervention group. Effect size, 95% confidence intervals, responder status analyses and reliable change indices were computed. Adherence to the intervention schedule and acceptability outcomes were good. There was no reliable change on B-CAM in the exercise group. Most physical performance measures benefited from the exercise training (effect sizes: 0.2 – 1.5). Although the 12-week exercise program improved physical capacity, it did not yield gains in cognitive ability in HIV. Further research is required to determine the exercise parameters that could benefit cognition. [ABSTRACT FROM AUTHOR]