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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]

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]

Black youth face significant disparities in HIV/sexually transmitted infection (STI) disease burden. Mental illness and emotion regulation are ontributors to HIV/STI risk, yet many HIV/STI prevention interventions do not address these factors. Project GOLD was a pilot randomized controlled trial of a psychoeducational HIV/STI prevention intervention designed to address the role of mental illness and emotion regulation in HIV/STI risk among heterosexually active Black youth aged 14–17 (N = 108). Participants were recruited from outpatient mental health treatment programs and general community settings via community partner referrals, face-to-face encounters, flyers and social media. Assessments were conducted pretest, immediate posttest, and at 3-, 6-, and 12-month follow-up. Although there were no statistically significant differences in behavior change from baseline, there were practically significant effect sizes among HIV condition participants when compared to the general health condition (e.g., fewer sexual partners at 6 months). An increase in theoretical mediators (e.g., condom use negotiation beliefs) was sustained at 12 months. HIV condition participants also reported lower depressive symptom severity, with statistical significance noted at immediate post and at 3 months. The findings highlight the importance and challenges of engaging Black youth in culturally and contextually relevant, developmentally and psychologically appropriate HIV/STI prevention interventions. [ABSTRACT FROM AUTHOR]

We conducted a randomized control trial to evaluate the impact of a novel technology-based intervention on HIV risks and condom use behaviors among Thai men who have sex with men (MSM). Between April 2016 and August 2017, participants aged 18 years and above, and having engaged in unprotected sex in past six months were randomly assigned to control and intervention arm, and received HIV testing at baseline, month 6 and 12. Intervention arm participants engaged in 12-monthly HIV/STI prevention educational sessions delivered via Vialogues.com. Of 76 MSM enrolled, 37 were randomized to intervention and 39 to control arm. Median age was 28 (IQR 24–32) years. Thirty-three (89.2%) intervention arm participants completed all 12-monthly Vialogues sessions. At month 12, intervention arm had higher retention rate (p = 0.029) and higher median percentage of condom use for anal intercourse (p = 0.023) versus control arm. Over the 12-month period, intervention arm reported significant reduction in self-perceived HIV risk (p = 0.001), popper usage (p = 0.002), median number of sexual partners (p = 0.003), and increased median condom use percentage (p = 0.006). Our study highlights that "Vialogues" intervention significantly reduced number of sexual partners and condomless anal intercourse rates among Thai MSM, and has positive implications for reducing epidemic among key populations. [ABSTRACT FROM AUTHOR]

We conducted a randomized controlled trial among 305 truck drivers from two North Star Alliance roadside wellness clinics in Kenya to see if offering HIV testing choices would increase HIV testing uptake. Participants were randomized to be offered (1) a provider-administered rapid blood (finger-prick) HIV test (i.e., standard of care [SOC]) or (2) a Choice between SOC or a self-administered oral rapid HIV test with provider supervision in the clinic. Participants in the Choice arm who refused HIV testing in the clinic were offered a test kit for home use with phone-based posttest counseling. We compared HIV test uptake using the Mantel Haenszel odds ratio (OR) adjusting for clinic. Those in the Choice arm had higher odds of HIV test uptake than those in the SOC arm (OR = 1.5), but the difference was not statistically significant (p = 0.189). When adding the option to take an HIV test kit for home use, the Choice arm had significantly greater odds of testing uptake (OR = 2.8,p = 0.002). Of those in the Choice arm who tested, 26.9% selected the SOC test, 64.6% chose supervised self-testing in the clinic, and 8.5% took a test kit for home use. Participants varied in the HIV test they selected when given choices. Importantly, when participants who refused HIV testing in the clinic were offered a test kit for home use, an additional 8.5% tested. Offering truck drivers a variety of HIV testing choices may increase HIV testing uptake in this key population. [ABSTRACT FROM PUBLISHER]

As the HIV-infected population ages and the burden of chronic comorbidities increases, adherence to medications for HIV and diabetes and hypertension is crucial to improve outcomes. We pilot-tested a pictorial aid intervention to improve medication adherence for both HIV and common chronic conditions. Adult patients with HIV and diabetes (DM) and/or hypertension (HTN) attending a clinic for underserved patients and at risk for poor health outcomes were enrolled. Patients were randomized to receive either a pictorial aid intervention (a photographic representation of their medications, the indications, and the dosing schedule) or a standard clinic visit discharge medication list. Adherence to antiretroviral therapy (ART) for HIV and therapy for DM or HTN was compared. Predictors of ART adherence at baseline were determined using logistic regression. Medication adherence was assessed using medication possession ratio (MPR) for the 6-month interval before and after the intervention. Change in adherence by treatment group was compared by ANOVA. Among the 46 participants, there was a trend towards higher adherence to medications for HIV compared with medications for hypertension/diabetes (baseline median MPR for ART 0.92; baseline median MPR for the medication for the comorbid condition 0.79,p = 0.07). The intervention was feasible to implement and satisfaction with the intervention was high. With a small sample size, the intervention did not demonstrate significant improvement in adherence to medications for HIV or comorbid conditions. Patients with HIV are often medically complex and may have multiple barriers to medication adherence. Medication adherence is a multifaceted process and adherence promotion interventions require an approach that targets patient-specific barriers. [ABSTRACT FROM PUBLISHER]

Adherence to antiretroviral medication for the treatment of HIV is a significant predictor of virologic suppression and is associated with dramatic reductions in mortality and morbidity and other improved clinical outcomes for pediatric patient populations. Effective strategies for addressing adherence problems in youth infected with HIV are needed and require significant attention to the complex interplay of multiple, interacting causal risk factors that lead to poor self-care. Within the context of a pilot randomized trial, we evaluated the feasibility and initial efficacy of a multisystemic therapy (MST) intervention adapted to address HIV medication adherence problems against a usual care condition that was bolstered with a single session of motivational interviewing (MI). For 34 participating youth, health outcomes (viral load [VL] and CD4 count) were obtained from approximately 10 months pre-baseline through approximately 6 months post-baseline and self-reported medication adherence outcomes were obtained quarterly from baseline through 9 months post-baseline. Using mixed-effects regression models we examined within- and between-groups differences in the slopes of these outcomes. Feasibility was supported, with a 77% recruitment rate and near-maximal treatment and research retention and completion rates. Initial efficacy also was supported, with the MST condition but not the MI condition demonstrating statistically and clinically significant VL reductions following the start of treatment. There was also some support for improved CD4 count and self-reported medication adherence for the MST but not the MI condition. MST was successfully adapted to improve the health outcomes of youth poorly adherent to antiretroviral medications. Replication trials and studies designed to identify the mechanisms of action are important next steps. [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]

Ancillary service needs likely influence time to diagnosis and presentation for HIV care. The effect of both met and unmet needs on late presentation to HIV care is not well understood. We used baseline data from 348 people with HIV (PWH) with no prior HIV care who enrolled in iENGAGE (a randomized controlled trial (RCT) of an intervention to support retention in care) at one of four HIV clinics in the US. A standardized baseline questionnaire collected information on ancillary service needs, and whether each need was presently unmet. We examined covariates known to be associated with disease stage at presentation to care and their association with needs. We subsequently assessed the relationship of needs with CD4 accounting for those other covariates by estimating prevalence ratios (PR) using inverse probability weights. Most patients enrolling in the RCT were male (79%) and the majority were Black (62%); median age was 34 years. Prevalence of any reported individual need was 69%. One-third of the sample had a baseline CD4 cell count <200, 42% between 200 and 499 and 27% ≥500. There was no statistically significant association between need or unmet need and baseline CD4. In general, psychiatric health and SU issues (depression, anxiety, and drug use) were consistently associated with higher prevalence of need (met and unmet). Additionally, the Black race was associated with higher basic resource needs (housing: PR 1.67, 95%CI 1.08–2.59; transportation: PR 1.65, 95% CI 1.12–2.45). Ancillary service needs (met and unmet) were common among patients new to HIV care and impacted vulnerable subgroups. However, we found no evidence that reporting a specific individual need, whether met or unmet, was associated with a timely presentation to HIV care. The impact of needs on subsequent steps of the HIV care continuum will be examined with longitudinal data. [ABSTRACT FROM AUTHOR]

A cluster randomized controlled trial was initiated in Kenya to determine if full integration (FI) of HIV care, including HAART, into antenatal care (ANC) clinics improves health outcomes among HIV-infected women and exposed infants, compared to a non-integrated (NI) model. This article examines ANC clients' satisfaction with and preferences regarding HIV-integrated services. In this cross-sectional study, pregnant women attending five FI clinics (n=185) and four NI clinics (n=141) completed an interviewer-administered questionnaire following an ANC visit. By self-report, 55 women (17%) were HIV(+), 230 (71%) were HIV(−), and 40 (12%) did not know their HIV status. Among HIV-infected women, 79% attending FI clinics were very satisfied with their clinic visit compared to 54% of women attending NI clinics (P=0.044); no such difference was found among HIV-uninfected women. In multivariate analysis, overall satisfaction was also independently associated with satisfaction with administrative staff, satisfaction with health care providers, positive evaluation of wait time, and having encountered a receptionist. Full integration of HIV care into antenatal clinics can significantly increase overall satisfaction with care for HIV-infected women, with no significant decrease in satisfaction for HIV-uninfected women served in the same clinics. [ABSTRACT FROM PUBLISHER]

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]

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]

Postpartum HIV care retention rates are well below retention rates of the general adult population. The Maternal-Child Health Antiretroviral Therapy (MCH-ART) trial tested the benefit of integrating postpartum maternal ART and pediatric care through the end of breastfeeding compared to the standard of care of immediate postpartum referral of mother and infant to separate services. After the trial, twenty-one participants completed in-depth interviews to understand the acceptability of the service integration and the potentially differing "lived" experiences of the women randomized to the two conditions. Key findings include: (1) the MCH-ART integrated service was found to be acceptable, (2) women in the intervention condition expressed more negative feelings around the need to be transferred to general ART services and (3) women in the intervention condition perceived that they had more influence in selecting the clinic to which they would be transferred compared to those in the control group, although there was no actual difference by study design. Future work should more directly evaluate the impact of shared decision-making and long-term relationships with clinic staff on patient engagement and retention in HIV care. [ABSTRACT FROM AUTHOR]

We conducted in Kenya a mixed-methods randomised controlled trial (RCT) of a nurse-led palliative care intervention integrated with anti-retroviral therapy (ART) provision for the management of HIV. Here we report qualitative findings showing increased resistance to HIV-associated stigma among trial participants. A mixed method design was chosen to enable identification of the active ingredients of the intervention and exploration of participants’ experiences of receiving the intervention. The RCT was conducted from July 2011 to November 2012 in a community hospital in the city of Mombasa, Kenya, with a sample of 120 adults with HIV on ART. Thirty participants were purposively selected to take part in a qualitative exit interview, based on study arm and mental health outcome. Inductive thematic analysis revealed increased resistance to HIV-associated stigma in both the intervention and control groups. Specifically, patients in both groups described benefit from the social support, compassionate care, and open and respectful communication they received through study participation. Participants described improved self-image, increased access to social agency, and increased resistance to HIV-associated stigma. Our findings suggest that there is potential to increase resistance to stigma through simple mechanisms of support, compassion, and improved communication in routine care. The self-reported impact of trial participation on stigma also has implications for future trials in populations in resource-constrained settings where stigma is common. [ABSTRACT FROM AUTHOR]

Prior studies indicate a substantial link between maternal depression and early child health but give limited consideration to the direction of this relationship or the context in which it occurs. We sought to create a contextually informed conceptual framework of this relationship through semi-structured interviews with women that had lived experience of caring for an HIV-infected child while coping with depression and anxiety symptoms. Caregivers explained their role in raising healthy children as complex and complicated by poverty, stigma, and isolation. Caregivers discussed the effects of their own mental health on child well-being as primarily emotional and behavioral, and explained how looking after a child could bring distress, particularly when unable to provide desired care for sick children. Our findings suggest the need for investigation of the reciprocal effects of child sickness on caregiver wellness and for integrated programs that holistically address the needs of HIV-affected families. [ABSTRACT FROM AUTHOR]

There is a clear need for effective strategies to address the factors that affect retention, or lost-to-follow-up (LTFU) and adherence to HIV care and treatment. Depression in particular may play an important role in the high rates of LTFU along the prevention of mother-to-child HIV transmission (PMTCT) cascade in sub-Saharan Africa. This study assessed the association between prenatal depression and (1) LTFU or (2) uptake of PMTCT services. As part of a randomized control trial to evaluate the effect of conditional cash transfers on retention in and uptake of PMTCT services, newly diagnosed HIV-infected women, ≤32 weeks pregnant, registering for antenatal care (ANC), in 85 clinics in Kinshasa, Democratic Republic of Congo (DRC), were recruited and followed-up until LTFU, death, transfer out, or six weeks postpartum. Participants were interviewed at enrollment using a questionnaire which included the Patient Health Questionnaire (PHQ-9). Depression was defined as a PHQ-9 score of ≥15. Among 433 women enrolled, 51 (11.8%) had a PHQ-9 score ≥15 including 15 (3.5%) with a score ≥20. At six weeks postpartum, 67 (15.5%) were LFTU and 331 (76.4%) were in care and had accepted all available PTMCT services. Of participants with depression at enrollment, 17.7% (9/51) were LTFU at six weeks postpartum compared to 15.2% (58/382) among those without, but the association was not statistically significant. On the other hand, 78.4% (40/51) of participants with prenatal depression were in care at six weeks postpartum and had attended all their scheduled visits and accepted available services compared to 76.2% (291/382) among those without depression. In this cohort of newly diagnosed HIV-infected pregnant women, prenatal depression assessed with a PHQ-9 score ≥15 was not a strong predictor of LTFU among newly diagnosed HIV-infected women in Kinshasa, DRC. [ABSTRACT FROM PUBLISHER]

Independently, HIV infection and heavy alcohol use increase microbial translocation (MT) of gut products into systemic circulation. MT and consequent immune response have been linked to chronic inflammation and a host of negative health outcomes in individuals living with HIV. However, previous research has not systematically investigated the immune correlates of heavy drinking specifically within the HIV-positive population. This pilot study investigated MT and immune activation as a function of alcohol use in 21 HIV-positive men who met NIAAA criteria for heavy drinking. Participants averaged 46.7 ± 8.5 (mean ± standard deviation) years of age, 12.2 ± 9.2 years since HIV diagnosis, 337 ± 158 CD4 nadir, and 643 ± 245 current CD4 count. All participants were virologically suppressed on antiretroviral therapy. Data on alcohol use and immune function were collected at baseline and three-month follow-up. Plasma concentrations of markers of MT and immune activation (lipopolysaccharide (LPS), soluble CD14 (sCD14), endotoxin core antibody immunoglobulin M (EndoCAb)) were measured using enzyme-linked immunosorbent assays. Generalized estimating equation models tested alcohol use variables as predictors of LPS, sCD14, and EndoCAb levels. Greater quantity and frequency of drinking significantly predicted higher sCD14 levels (p’s < .01). Conversely, longer duration of abstinence from alcohol significantly predicted lower sCD14 levels (p < .001). These results remained significant after controlling for age, HIV duration, smoking status, current CD4 count, CD4 nadir, and antiretroviral drug type. In addition, participants with ≥50% relative reduction in drinks per week showed a significant decrease (p < .05) in sCD14 from baseline to three-month follow-up. This pilot study provides preliminary evidence that heavy drinking may increase a key inflammatory marker in HIV-infected individuals with suppressed infection. [ABSTRACT FROM AUTHOR]

HIV-affected families report higher rates of harmful alcohol use, intimate partner violence (IPV) and family conflict, which can have detrimental effects on children. Few evidence-based interventions exist to address these complex issues in Sub-Saharan Africa. This mixed methods study explores the potential of a family-based intervention to reduce IPV, family conflict and problems related to alcohol use to promote child mental health and family functioning within HIV-affected families in post-genocide Rwanda. A family home-visiting, evidence-based intervention designed to identify and enhance resilience and communication in families to promote mental health in children was adapted and developed for use in this context for families affected by caregiver HIV in Rwanda. The intervention was adapted and developed through a series of pilot study phases prior to being tested in open and randomized controlled trials (RCTs) in Rwanda for families affected by caregiver HIV. Quantitative and qualitative data from the RCT are explored here using a mixed methods approach to integrate findings. Reductions in alcohol use and IPV among caregivers are supported by qualitative reports of improved family functioning, lower levels of violence and problem drinking as well as improved child mental health, among the intervention group. This mixed methods analysis supports the potential of family-based interventions to reduce adverse caregiver behaviors as a major mechanism for improving child well-being. Further studies to examine these mechanisms in well-powered trials are needed to extend the evidence-base on the promise of family-based intervention for use in low- and middle-income countries. [ABSTRACT FROM PUBLISHER]

In order to increase patient active engagement during patient–provider interactions, we developed and implemented patient training sessions in four antiretroviral therapy (ART) clinics in Namibia using a “Patient Empowerment” training curriculum. We examined the impact of these trainings on patient–provider interactions after the intervention. We tested the effectiveness of the intervention using a randomized parallel group design, with half of the 589 enrolled patients randomly assigned to receive the training immediately and the remaining randomized to receive the training 6 months later. The effects of the training on patient engagement during medical consultations were measured at each clinic visit for at least 8 months of follow-up. Each consultation was audiotaped and then coded using the Roter Interaction Analysis System (RIAS). RIAS outcomes were compared between study groups at 6 months. Using intention-to-treat analysis, consultations in the intervention group had significantly higher RIAS scores in doctor facilitation and patient activation (adjusted difference in score 1.19,p = .004), doctor information gathering (adjusted difference in score 2.96,p = .000), patient question asking (adjusted difference in score .48,p = .012), and patient positive affect (adjusted difference in score 2.08,p = .002). Other measures were higher in the intervention group but did not reach statistical significance. We have evidence that increased engagement of patients in clinical consultation can be achieved via a targeted training program, although outcome data were not available on all patients. The patient training program was successfully integrated into ART clinics so that the trainings complemented other services being provided. [ABSTRACT FROM PUBLISHER]

The double-blind phase of the randomized ANRS IPERGAY trial, evaluating sexual activity-based oral HIV pre-exposure prophylaxis (PrEP), was conducted among high-risk men who have sex with men (MSM). Results showed an 86% (95% CI: 40–98) relative reduction in HIV incidence among participants with tenofovir disoproxil fumarate–emtricitabine vs. placebo. The present pooled analysis aimed to analyze (i) participants’ adherence to the prescribed treatment and/or condom use during sexual intercourse and (ii) sexual behavior during the double-blind phase of the study. Four hundred MSM were enrolled in the trial. Every 2 months they completed online questionnaires collecting sexual behavior and PrEP adherence data regarding their most recent sexual intercourse. A total of 2232 questionnaires (M0–M24) were analyzed. Changes over time were evaluated using a mixed model accounting for multiple measures. Irrespective of sexual partner and practice type, on average, 42.6% (min: 32.1–max: 45.8%) reported PrEP use only during their most recent episode of sexual intercourse; 29% (22.9–35.6%) reported both PrEP and condom use; 11.7% (7.2–18.9%) reported condom-use only, and 16.7% (10.8–29.6%) reported no PrEP or condom use with no significant change during the study. Scheduled (i.e., correct) PrEP use was reported on average by 59.0% (47.2–68.5%) of those reporting PrEP use during their most recent sexual intercourse. Overall, 70.3% (65.3–79.4%) and 69.3% (58.3–75.4%) of participants reported, respectively, condomless anal and condomless receptive anal intercourse during their most recent sexual encounter without significant change during follow-up. Overall, on average 83.3% (min: 70.4–max: 89.2%) of participants protected themselves by PrEP intake or condom use or both during the trial, and no increase in at-risk sexual practices was observed. None of these indicators showed significant trend during the follow-up, although we found a tendency toward decrease (p = .19) of the median number of sexual partners strengthening the absence of behavioral disinhibition. On-demand PrEP within a comprehensive HIV prevention package could improve prevention in MSM. [ABSTRACT FROM PUBLISHER]

HIV-infected patients receiving antiretroviral therapy have increased risk of metabolic syndrome, including dyslipidemia. In this study, we determined whether individual nutritional counseling reduced dyslipidemia, particularly low-density lipoprotein (LDL) cholesterol, among HIV-infected patients with dyslipidemia not currently taking lipid-lowering medication. We conducted a randomized 24-week trial among HIV-infected patients with dyslipidemia who were on antiretroviral therapy and were eligible to initiate therapeutic lifestyle changes according to the Thai National Cholesterol Education Program. Participants were randomly assigned to an intervention group that received individual counseling with a nutritionist for seven sessions (baseline, weeks 2, 4, 8, 12, 18, and 24) and a control group that received standard verbal diet information at baseline and nutritional counseling only at week 24. A 24-h recall technique was used to assess dietary intake for both groups at baseline and week 24. Lipid profile (total cholesterol, LDL, high-density lipoprotein (HDL), and triglyceride) was measured at baseline and after 12 and 24 weeks of therapy. An intention-to-treat and linear mixed model were used. Seventy-two patients were randomly assigned, and 62 (86%) participants completed their lipid profile test. After 12 weeks of follow-up, there were significant reductions in the intervention group for total cholesterol (−14.4 ± 4.6 mg/dL,P = .002), LDL cholesterol (−13.7 ± 4.1 mg/dL,P = .001), and triglyceride (−30.4 ± 13.8 mg/dL,P = .03). A significant reduction in LDL cholesterol was also observed in the control group (−7.7 ± 3.8 mg/dL,P = .04), but there were no significant differences in change of mean lipid levels between the groups at 12 weeks of follow-up. After 24 weeks, participants assigned to the intervention group demonstrated significantly greater decreases in serum total cholesterol (−19.0 ± 4.6 vs. 0.2 ± 4.3 mg/dL,P = .003) and LDL cholesterol (−21.5 ± 4.1 vs. −6.8 ± 3.8 mg/dL,P = .009). There were no significant changes in HDL cholesterol or triglyceride levels in either group. [ABSTRACT FROM PUBLISHER]

The majority of HIV-infected children in sub-Saharan Africa have not been informed of their HIV status. Caregivers are reluctant to disclose HIV status to their children because of concern about the child’s ability to understand, parental sense of guilt, and fear of social rejection and isolation. We hypothesized that the low prevalence of pediatric HIV disclosure in Ghana is due to lack of accurate HIV information and high HIV stigma among caregivers. This is a preliminary analysis of baseline data of an HIV pediatric disclosure intervention study in Ghana (“Sankofa”). “Sankofa” – is a two-arm randomized controlled clinical trial comparing disclosure intervention plus usual care (intervention arm) vs usual care (control arm) at Korle-Bu Teaching Hospital (KBTH; control arm) and Komfo-Anokye Teaching Hospital (KATH; intervention arm). We enrolled HIV-infected children, ages 7–18 years who do not know their HIV status, and their caregivers. Baseline data of caregivers included demographic characteristics; Brief HIV Knowledge Questionnaire (HIV-KQ-18); Brief Illness Perception Questionnaire; and HIV Stigma Scale. Simple and multivariable linear regression analyses were used to assess the relationship between caregiver characteristics and HIV knowledge, stigma, and illness perception. Two hundred and ninety-eight caregivers were enrolled between January 2013 and July 2014 at the two study sites; KBTH (n= 167) and KATH (n= 131). The median age of caregivers was 41 years; 80.5% of them were female and about 60% of caregivers were HIV-positive. Seventy-eight percent of caregivers were self-employed with low household income. In both unadjusted and adjusted analyses, HIV negative status and lower level of education were associated with poor scores on HIV-KQ. HIV positive status remained significant for higher level of stigma in the adjusted analyses. None of the caregiver’s characteristics predicted caregiver’s illness perception. Intensification of HIV education in schools and targeted community campaigns are needed. [ABSTRACT FROM AUTHOR]

Potential for widespread transmission of HIV/AIDS among American Indian (AI) adolescents exists, yet no evidence-based interventions (EBIs) have been adapted and evaluated with this population. Intensive psychoeducation may improve knowledge and decision-making which could potentially translate to reductions in HIV risk behaviors. A peer group randomized controlled comparison of an adapted EBI vs. control was delivered over an eight-day summer basketball camp in one reservation-based tribal community to adolescents ages 13–19. Outcome data were gathered immediately post-camp and at 6 and 12 months follow-up. Self-selected peer groups were randomized to intervention (n= 138) or control (n= 129) conditions for a total sample of 267 participants (56.2% female), mean age 15.1 years (SD = 1.7). Intervention participants had better condom use self-efficacy post-camp (Adjusted Mean Difference [AMD] = −0.75,p< 0.005) and at 6 (AMD = −0.44,p< 0.005) and 12 months (AMD = −0.23,p< 0.05) follow-up. Intervention participants also had higher HIV prevention and transmission knowledge (post-camp: AMD = 0.07,p< 0.01; 6 months: AMD = 0.06,p< 0.01) were more likely to believe condoms prevent sexually transmitted infections (post-camp: RR = 1.41,p< 0.005; 6 months: RR = 1.34,p< 0.05), to talk with an adult about HIV/AIDS (post-camp: RR=1.78,p< 0.005; 6 months: RR = 1.14,p< 0.005), had higher partner negotiation efficacy related to substance use during sex (post-camp: AMD = 0.37,p< 0.01), and were more likely to intend to use a condom (post-camp: RR = 1.39,p< 0.01). The adapted intervention had short- and medium-term impacts on AI adolescent risk for HIV/AIDS, but attenuated at 12 months. Intervention delivery through a community-based camp is feasible and acceptable with strong retention. Additional study is needed to evaluate the adapted intervention's impact on sexual risk behaviors and if booster sessions and parent involvement translate to long-term impacts. [ABSTRACT FROM AUTHOR]

This paper describes implementation research of an intervention in a complex HIV prevention randomised trial in southern Africa. Researchers collected stories of change attributed by 106 community members to an audio-drama edutainment intervention in 41 sites in Botswana, Namibia and Swaziland. The team analysed themes in the stories following a behaviour change model of conscious knowledge, attitudes, subjective norms, intention to change, agency, discussion and action (CASCADA). Storytellers attributed positive changes to the intervention in the areas of gender violence, multiple sexual partners, transactional and intergenerational sex and condom use. Their stories illustrate each of the steps in the CASCADA behaviour change model. As well as supporting an enabling environment for other interventions in the trial, the audio-drama also helped some participants to make personal changes. Collecting and discussing the stories were encouraging for the trial fieldworkers. Documenting the experiences of participants and framing the analysis of stories in an explicit behaviour change model allowed us to reflect on potential mechanisms and pathways through which the intervention impacts on individuals and communities. It helped in the design of the quantitative instruments to measure intermediate outcomes of the trial. [ABSTRACT FROM PUBLISHER]

We sought to develop and implement collaborative depression care in human immunodeficiency virus (HIV) clinics in a project called HIV Translating Initiatives for Depression into Effective Solutions (HITIDES). Here we describe: (i) the formative evaluation (FE) conducted prior to implementation; (ii) the process used to adapt the primary care collaborative care model for depression to specialty HIV clinics; and (iii) the intervention itself. The overall design of HITIDES was a multi-site randomized trial in United States Department of Veterans Affairs (VA) HIV clinics comparing the depression collaborative care intervention to usual depression care. Qualitative methods were used for the FEs and informed the evidence-based quality improvement (EBQI) methods that were used for adapting and implementing the intervention. Baseline assessments were completed by 249 depressed HIV participants. Summaries of respective key informant interviews with eight HIV patients who were receiving depression treatment and 25 HIV or mental health (MH) providers were presented to each site. EBQI methods were used to tailor the HITIDES intervention to each site while maintaining true to the evidence base for depression collaborative care. EBQI methods provided a useful framework for intervention adaptation and implementation. The HITIDES study provides the opportunity to evaluate collaborative depression care in a specialty physical health clinic setting with a population that has a high prevalence of depression and MH comorbidity. [ABSTRACT FROM AUTHOR]