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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]

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]

Men who have sex with men (MSM) continue to be the largest risk group for HIV infections in the U.S., where crystal methamphetamine abuse heightens risk for HIV infection through greater engagement in condomless anal sex (CAS). Existing treatments lack attention to replacement activities or the role of depressed mood. Behavioral activation (BA) is an evidence-based approach for depression that involves identifying and participating in pleasurable, goal-directed activities. We hypothesize, for MSM abusing crystal methamphetamine, re-learning how to engage in non-drug-using aspects of life would facilitate their ability to benefit from sexual risk reduction (SRR) counseling. Project IMPACT was a pilot randomized-controlled-trial. Forty-six MSM at sexual risk of acquiring HIV who met DSM-IV criteria for crystal methamphetamine dependence were enrolled. Of those MSM, 41 were randomized: 21 were assigned to the intervention, two sessions of SRR, ten sessions of BA with SRR, and one session of relapse prevention; 20 participants were assigned to a control condition (two sessions of SRR). At the acute post-intervention visit, intervention participants reported an average of 3.2 CAS acts with men who were HIV-infected or whose status they did not know, compared to 4.5 among control participants (β = −0.36; 95% CI: −0.69, −0.02; p = 0.035). At the 6-month post-intervention visit, intervention participants reported 1.1 CAS acts with men who were HIV-infected or whose status they did not know compared to 2.8 among control participants (β = −0.95; 95% CI: −1.44, −0.46; p < 0.0001). Similarly, intervention participants reported 1.0 CAS acts under the influence of crystal methamphetamine with men who were HIV-infected or whose status they did not know compared to 2.5 among control participants (β = −0.87; 95% CI: −1.38, −0.36; p = 0.0005). Lastly, intervention participants reported more continuous days abstaining from crystal methamphetamine compared to control (50.1 vs. 39.0, respectively) (β = 0.25; 95% CI: 0.16, 0.34; p < 0.0001). Findings are encouraging, provide evidence of feasibility and acceptability, and demonstrate initial efficacy for reducing sexual risk for HIV and crystal methamphetamine use. [ABSTRACT FROM AUTHOR]

Lack of condom use by married or cohabiting couples in populations with high rates of HIV infection has become a significant public health issue. This study investigated whether an HIV risk-reduction intervention (RRI) would increase condom use when delivered to serodiscordant couples as a unit. Of the 62 couples that were screened, 30 serodiscordant couples were enrolled in the study, and randomized 2:1 to an immediate intervention-waitlist control study. The 12-week intervention focused on communication, problem-solving, and negotiation skills. Participants were assessed at baseline, three and six months after the intervention. The main outcome measures were consistent condom use, HIV seroconversion and fidelity to the programme. The use of condoms increased for both the intervention and control groups after receiving a 12-week RRI. Group comparisons showed a significant difference at three months, with a significantly higher mean proportion of condom-protected sex acts (p = 0.0119) between the control and intervention groups, the later showing an increase in condom use. No seroconversion was detected, and the overall retention rate of participants was 83.33%. Counselling heterosexual couples as a unit prompted an increase in condom use, but sustained condom use remains a challenge. [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]

Research has indicated that mental health disorders, particularly anxiety, predicts poorer antiretroviral medication adherence among persons living with HIV/AIDS (PLWHA). The present study tests a novel six-session Cognitive-Behavioral Therapy-based integrated treatment/management program for PLWHA with concurrent anxiety delivered in community health clinics Houston, Texas. Twenty-Seven PLWHA (Mage = 48.5, SD = 8.9, 44.4% female) were recruited for a proof-of-concept study and randomized to either an active treatment condition, or a waitlist control condition of equal length. Participants were assessed pre-randomization, at the mid-treatment time point (after three sessions for the active participants and three weeks for the control participants) and post-treatment (six sessions for active participants, six weeks for control participants). Data were examined used Bayesian multilevel models. Results indicated a reliable (99.87% posterior probability of a moderating effect) interaction between active and control groups for depressive symptoms and reliable (99.65% probability) interaction for anxiety symptoms. Results indicated an unreliable interaction for combined antiretroviral therapy adherence. These findings are discussed in terms of the feasibility and potential utility of administering an anxiety-reduction therapy program designed for PLWHA with HIV medication adherence difficulties. [ABSTRACT FROM AUTHOR]

Although HIV-infected men who have sex with men (MSM) constitute a newly emerged high-risk group in China, little research outside Western countries is available on effective intervention programs to enhance their well-being. The purpose of this randomized controlled trial was to evaluate the efficacy of a group intervention program designed to improve the well-being and adaptive coping strategies of 60 HIV-infected MSM in Beijing, China, randomly assigned either to the intervention group for participation in four weekly sessions or to the control group for placement on a waiting list. They all completed measurements at pre- and postintervention. Compared with the control group, the intervention group reported significantly increased problem-focused coping strategies and levels of posttraumatic growth (PTG) as well as decreased symptoms of posttraumatic stress disorder (PTSD) at the completion of the intervention. In addition, mediation analysis showed that changes in problem-focused coping strategies mediated the intervention effect on increases in PTG; however, the mediating effect of coping strategies on the association of intervention and PTSD was not significant. This study provides empirical evidence for conducting psychological intervention to promote the well-being of HIV-infected MSM. The findings also elucidate the mechanism through which intervention improved PTG. [ABSTRACT FROM AUTHOR]

HIV-infected youth experience many stressors, including stress related to their illness, which can negatively impact their mental and physical health. Therefore, there is a significant need to identify potentially effective interventions to improve stress management, coping, and self-regulation. The object of the study was to assess the effect of a mindfulness-based stress reduction (MBSR) program compared to an active control group on psychological symptoms and HIV disease management in youth utilizing a randomized controlled trial. Seventy-two HIV-infected adolescents, ages 14-22 (mean age 18.71 years), were enrolled from two urban clinics and randomized to MBSR or an active control. Data were collected on mindfulness, stress, self-regulation, psychological symptoms, medication adherence, and cognitive flexibility at baseline, post-program, and 3-month follow-up. CD4+ T lymphocyte and HIV viral load (HIV VL) counts were also pulled from medical records. HIV-infected youth in the MBSR group reported higher levels of mindfulness (P = .03), problem-solving coping (P = .03), and life satisfaction (P = .047), and lower aggression (P = .002) than those in the control group at the 3-month follow-up. At post-program, MBSR participants had higher cognitive accuracy when faced with negative emotion stimuli (P = .02). Also, those in the MBSR study arm were more likely to have or maintain reductions in HIV VL at 3-month follow-up than those in the control group (P = .04). In our sample, MBSR instruction proved beneficial for important psychological and HIV-disease outcomes, even when compared with an active control condition. Lower HIV VL levels suggest improved HIV disease control, possibly due to higher levels of HIV medication adherence, which is of great significance in both HIV treatment and prevention. Additional research is needed to explore further the role of MBSR for improving the psychological and physical health of HIV-positive youth. [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]

Depression and substance use are significant obstacles to effective HIV care. Using data derived from a randomized controlled trial of persons with HIV who are homeless or marginally housed, this study assesses the utility of antidepressant treatment among persons with HIV, depression, and active substance use. Participants were diagnosed with depressive disorders and randomly assigned to receive directly observed therapy with fluoxetine or a referral to community mental health treatment. Assessments, conducted at baseline and every 3 months over a 9-month period, included the Hamilton Rating Scale for Depression, the Beck Depression Inventory II, and self-report of alcohol, crack, cocaine, heroin, or methamphetamine use in the past 90 days. To investigate the effect of antidepressant treatment in the setting of active substance use, the authors fit mixed-effects linear regression models to estimate the effect of directly observed fluoxetine on depressive symptom severity after stratifying by any alcohol use or any illicit drug use. To investigate whether alcohol use or illicit drug use moderated the antidepressant treatment response, the authors examined the interaction terms. The effect of directly observed fluoxetine treatment on depression symptom severity was statistically significant irrespective of alcohol use status. When stratified by illicit drug use status, the effect of directly observed fluoxetine treatment on depression symptom severity was statistically significant only among persons who did not use illicit drugs. The interaction terms were not statistically significant. This study found a benefit of antidepressant treatment in persons with HIV, depression, and alcohol use. In addition, this study found no evidence that either alcohol use or illicit drug use moderates the antidepressant treatment response. Altogether, these findings support the use of antidepressant medication in this population. The public health impact of research in this area is significant given the known adverse effects of depression on HIV-related health outcomes. ClinicalTrials.gov Identifier: NCT00338767. [ABSTRACT FROM AUTHOR]

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]

Integration of family planning (FP) services into HIV care and increasing male partner involvement in FP are being explored as strategies to reduce unmet need for contraception. Providers' views can give valuable insight into current FP care. We evaluated the perspectives of HIV care providers working at HIV clinics in Nyanza Province, Kenya, on male partner involvement in FP. This qualitative study was part of a cluster-randomized controlled trial evaluating the impact of integrating FP into HIV services on contraceptive prevalence among HIV-positive patients in Nyanza Province, Kenya. Thirty individual interviews were conducted among health-care workers at 11 HIV care facilities in Nyanza Province, Kenya. Interviews were conducted from integrated and control sites one year after implementation of FP/HIV integration. Data were transcribed and analyzed using grounded theory methods and ATLAS-ti. Providers supported male partner inclusion when choosing FP and emphasized that decisions should be made collaboratively. Providers believed that men have traditionally played a prohibitive role in FP but identified several benefits to partner involvement in FP decision-making including: reducing relationship conflicts, improving FP knowledge and contraceptive continuation, and increasing partner cohesion. Providers suggested that integrated FP/HIV services facilitate male partner involvement in FP decision-making since HIV-positive men are already established patients in HIV clinics. Some providers stated that women had a right to choose and start FP alone if their partners did not agree with using FP. Integrated FP services may be a useful strategy to help increase male participation to reduce the unmet FP need in sub-Saharan Africa. It is important to determine effective ways to engage male partners in FP, without impinging upon women's autonomy and reproductive rights. [ABSTRACT FROM AUTHOR]

Depressive symptoms are highly prevalent, underdiagnosed, and undertreated in people living with HIV/AIDS (PLWH), and are associated with poorer health outcomes. This randomized controlled trial examined the effects of the HIV/AIDS Symptom Management Manual self-care symptom management strategies compared with a nutrition manual on depressive symptoms in an international sample of PLWH. The sample consisted of a sub-group (N=222) of participants in a larger study symptom management study who reported depressive symptoms. Depressive symptoms of the intervention (n=124) and control (n=98) groups were compared over three months: baseline, one-month, and two-months. Use and effectiveness of specific strategies were examined. Depressive symptom frequency at baseline varied significantly by country (χ212.9;p=0.04). Within the intervention group there were significant differences across time in depressive symptom frequency [F(2, 207) = 3.27,p=0.05], intensity [F(2, 91) = 4.6,p=0.01], and impact [F(2, 252) = 2.92,p= 0.05), and these were significantly lower at one month but not at two months, suggesting that self-care strategies are effective in reducing depressive symptoms, however effects may be short term. Most used and most effective self-care strategies were distraction techniques and prayer. This study suggests that people living with HIV can be taught and will employ self-care strategies for management of depressive symptoms and that these strategies are effective in reducing these symptoms. Self-care strategies are noninvasive, have no side-effects, and can be readily taught as an adjunct to other forms of treatment. Studies are needed to identify the most effective self-care strategies and quantify optimum dose and frequency of use as a basis for evidence-based practice. [ABSTRACT FROM PUBLISHER]

The objective of the study was to assess the effectiveness of group counseling, using a problem-solving therapy approach, on reducing depressive symptoms and increasing prenatal disclosure rates of HIV status among HIV-positive pregnant women living in Dar es Salaam, Tanzania. A randomized controlled trial was performed comparing a six-week structured nurse–midwife facilitated psychosocial support group with the standard of care. Sixty percent of women in the intervention group were depressed post-intervention, versus 73% in the control group [Relative Risk (RR) = 0.82, 95% confidence interval (CI): 0.67–1.01, p=0.066]. HIV disclosure rates did not differ across the two study arms. However, among those women who disclosed, there was a significantly higher level of overall personal satisfaction with the response to disclosure from family and friends among women in the treatment (88%) compared to the control group (62%; p=0.004). The results indicate reductions in the level of depressive symptoms comparable with major depressive disorder (MDD) for HIV-positive pregnant women participating in a group counseling intervention. Although the psychosocial group counseling did not significantly increase disclosure rates, an improvement in the level of personal satisfaction resulting from disclosure was associated with the intervention. This suggests that the counseling sessions have likely reduced the burden of depression and helped clients better manage partner reactions to disclosure. Public agencies and non-governmental organizations working in Tanzania and similar settings should consider offering structured psychosocial support groups to HIV-positive pregnant women to prevent poor mental health outcomes, promote early childhood development, and potentially impact HIV-related disease outcomes in the long term. [ABSTRACT FROM AUTHOR]

Mpumalanga Province, South Africa has one of the highest HIV/AIDS diagnosis rates among pregnant women (~29.4%). This study sought to enhance male involvement in pregnancy to increase HIV disclosure, sexual communication, HIV knowledge and reduce unprotected sex. Participants attending Antenatal Clinics (ANC) completed HIV counseling and testing and were enrolled with male partners (n = 239 couples, 478 individuals). Twelve ANCs were randomly assigned to provide a prevention of mother-to-child transmission (PMTCT) intervention or the standard of care, health education sessions plus PMTCT. Participants were assessed at baseline and post-intervention (approximately 6-8 weeks post-baseline) on demographics, sexual behavior, HIV-related knowledge, and conflict resolution strategies. Experimental participants increased HIV knowledge, use of negotiation, and decreased intimate partner violence. Additionally, they were more likely to have increased condom use from baseline to post-intervention (OR = 5.1, 95% CI =[2.0, 13.3]). Seroconversions in the control condition exceeded experimental (6 vs. 0). HIV serostatus disclosure to partner did not increase over time for men or women within the experimental or control condition. Male involvement in pregnancy may be an important strategy to reduce sexual risk behavior and HIV transmission. Results support the utility of group interventions to enhance communication and HIV knowledge among pregnant couples. [ABSTRACT FROM AUTHOR]

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]

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]

The goal of the study was to investigate moderators of intervention effect of a guided Internet-based self-help cognitive behavioral intervention for people with HIV and depressive symptoms. This study was part of a randomized controlled trial where the intervention was found to be effective in reducing depressive symptoms, compared to an attention-only control group. Demographic characteristics (e.g., age), HIV characteristics (e.g., duration of HIV), and psychological characteristics (e.g., coping self-efficacy) were investigated as potential moderators of intervention effect. In 2015, 188 people with HIV and depressive symptoms were included in the study: 97 were randomized to the intervention group and 91 to the control group. Two moderators of intervention effect were found: coping self-efficacy and baseline depression severity. Participants with low coping self-efficacy and baseline depression severity improved more in the intervention group than in the control group, and participants with high coping self-efficacy and baseline depression severity improved in both groups. The results indicate that the intervention may be provided to all people with HIV and depressive symptoms. It may be especially important for people with HIV and low coping self-efficacy to start with the intervention since they show less improvement in the control group with only attention. Trial registration: Nederlands Trialregister NTR5407, September 11, 2015. [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]

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]

This paper describes the rationale, design, methods, and baseline results of a randomized controlled trial to evaluate the impact of an adapted evidence-based intervention (EBI), “Respecting the Circle of Life” (RCL) to reduce behavioral risks for HIV/AIDS among American Indian (AI) adolescents. A participatory approach shaped intervention adaptation and study design. A total of 267 participants (aged 13–19) were randomized by peer groups of the same sex to receive the RCL intervention or a control condition. Self-report assessments were administered at four intervals. The sample was predominately female (57%), had low HIV knowledge prevention scores, early sexual initiation (mean 14.6 years), and 56% reported intention to use a condom at next sex. Baseline characteristics were evenly distributed between groups with the exception of age and extrinsic reward scores. This is the first rigorous evaluation of an adapted EBI for HIV/AIDS prevention among AI adolescents, an at-risk and understudied population. [ABSTRACT FROM AUTHOR]

Despite high rates of co-occurring tobacco use and anxiety among persons living with HIV, evidence-based interventions for these individuals are limited. An existing cognitive-behavioral treatment protocol for smoking cessation and anxiety (Norton, P. J., & Barrera, T. L. (2012). Transdiagnostic versus diagnosis-specific CBT for anxiety disorders: A preliminary randomized controlled noninferiority trial. Depression and Anxiety, 29(10), 874-882. https://doi.org/10.1002/da.21974) was modified to address transdiagnostic constructs, such as anxiety sensitivity, distress tolerance, and depressive symptomatology (Labbe, A. K., Wilner, J. G., Kosiba, J. D., Gonzalez, A., Smits, J. A., Zvolensky, M. J., ... O'Cleirigh, C. (2017). Demonstration of an Integrated Treatment for Smoking Cessation and Anxiety Symptoms in People with HIV: A Clinical Case Study. Cognitive and Behavioral Practice, 24(2), 200-214. https://doi.org/10.1016/j.cbpra.2016.03.009). This study examines the feasibility and acceptability of the intervention as determined from qualitative data from structured exit interviews from 10 participants who completed treatment. Results demonstrated that participants were very motivated to quit smoking and enrolled in the program for health-related reasons and to be able to quit. Participants found nearly all the treatment components to be useful for reaching their smoking cessation goal and in managing emotional dysregulation. Last, all participants stated that they would strongly recommend the treatment program. This qualitative study provides initial evidence for the feasibility and acceptability of a modified smoking cessation treatment protocol for HIV+ individuals with anxiety and emotional dysregulation. Future research will focus on evaluating the efficacy of the protocol in a full-scale randomized controlled trial, as well as working to collect qualitative data from participants who discontinue treatment to better understand reasons for treatment attrition. [ABSTRACT FROM AUTHOR]

Technology-based interventions for behavior change, such as adherence monitors and SMS text messages, can improve adherence to HIV antiretroviral therapy. It is unclear, however, how the effects of such interventions are maintained when interventions are withdrawn. We explored resiliency of people living with HIV in coping with adherence to antiretroviral therapy (ART) after withdrawing an adherence support intervention of real-time adherence monitors linked to SMS text messages at study closure. This is a qualitative study conducted with former participants of a pilot randomized controlled trial after study closure. Between April 2016 and November 2016, we used convenient sampling to interview 28 of the 62 participants from the pilot trial, which was conducted in rural Uganda. Interviews elicited information on experiences of taking ART in the absence of the intervention, coping strategies, and changes in social support interactions. Data were analyzed inductively using content analysis. Most participants demonstrated resilience through learning adherence from the intervention; and internalizing the habit of medication adherence. They seemed to have a sense of self-esteem, positive thinking, and access to supportive relationships. Other participants employed adaptive coping strategies, such as using alternative cues (e.g., alarms), accessing spiritual support, and adjusting their medication time to their routine. A few participants lacked resiliency, lost the habit and struggled with adherence. They were dependent on the intervention, appeared isolated and psychologically stressed, and were unable to overcome challenges associated with poor social support systems. Intervention-related benefits may or may not persist after the intervention is withdrawn. Contingent on individuals" underlying characteristics and relationships, participants manifested resiliency through learning and internalization, as well as using alternative coping strategies. Such resiliency could facilitate the use of short-term interventions, which are particularly important for resource-limited settings. Participants should be referred to available additional support at study closure when needed. [ABSTRACT FROM AUTHOR]

The objective of this study is to determine if pediatric advance care planning (pACP) increases adolescent/family congruence in end-of-life (EOL) treatment preferences longitudinally. Adolescents aged 14–21 years with HIV/AIDS and their families were randomized (N = 105 dyads) to three-60-minute sessions scheduled one week apart: either the pACP intervention (survey administered independently, facilitated conversation with adolescent and family present, completion of legal advance directive document with adolescent and family present) or an active control (developmental history, safety tips, nutrition and exercise education). This longitudinal, single-blinded, multi-site, randomized controlled trial was conducted in six pediatric hospital-based HIV-clinics, located in high HIV mortality cities. The Statement of Treatment Preferences measured adolescent/family congruence in EOL treatment preferences at immediately following the facilitated pACP conversation (Session 2), and at 3-month post-intervention. The mean age of adolescent participants was 18 years (range 14–21 years); 54% were male; and 93% were African-American. One-third had an AIDS diagnosis. Immediately post-intervention the Prevalence Adjusted Bias Adjusted Kappa showed substantial treatment preference agreement for pACP dyads compared to controls (High burden/low chance of survival, PABAK = 0.688 vs. 0.335; Functional impairment, PABAK = 0.687 vs. PABAK= 0.34; Mental impairment, PABKA = 0.717 vs. 0.341). Agreement to limit treatments was greater among intervention dyads than controls (High burden: 14.6% vs. 0%; Functional impairment = 22.9% vs. 4.4%; and Mental impairment: 12.5% vs. 4.4%). Overall treatment preference agreement among pACP dyads was high immediately post-intervention, but decreased over time. In contrast, treatment agreement among control dyads was low and remained low over time. As goals of care change over time with real experiences, additional pACP conversations are needed. [ABSTRACT FROM PUBLISHER]

Background: Smartphones with programmable apps may offer innovative interactive interventions for improving adherence among people living with HIV with substance use problems. Methods: This pilot randomized controlled trial sought to primarily determine the usability and feasibility of using a smartphone-based intervention called Heart2HAART as an adjunct to directly observed treatment with adherence counseling compared to directly observed treatment with adherence counseling alone among those with HIV and a history of substance use over a three-month time frame. Participants in the Heart2HAART condition completed an additional survey on usability and acceptability. Adherence was measured using unannounced pill counts assessed via a phone call. Results: Twenty-eight participants were randomized to receive Heart2HAART (n = 19) or control (n = 9). All were receiving either weekly (n = 9) or daily (n = 19) observed treatment. Among those randomized to Heart2HAART, 63.2% reported no difficulty using the Heart2HAART smartphone application and 94.7% responded that the medication reminders did not interfere negatively with their activities. On average participants used Heart2HAART application 56.8 times over the three-month trial. In analyses adjusting for age, there was no difference in adherence to HAART medication between the Heart2HAART and control group as evaluated by the random pill count assessment (P = .29). Conclusions: Heart2HAART was feasible to use during a threemonth pilot trial. Future studies may evaluate a more tailored approach, with more robust contingency management. [ABSTRACT FROM AUTHOR]

Human immunodeficiency virus (HIV) infection affects the quality of life of infected people. It is well known that empowerment is important for appropriate access to health care and quality of care. However, there is currently limited availability of explicit methods to increase the empowerment of HIV-infected people. This study aimed to develop and test the feasibility of a social self-value package as an empowerment intervention method for HIV-infected people. One group included 8-10 participants and each session lasted for one and half hours. Six sessions in total were developed and one session was conducted in one week. A total of 66 participants were randomly selected for participating in the package, assessed its feasibility both quantitatively and qualitatively. Attitudes towards HIV-related issues significantly and positively changed after each session. Client satisfaction and acceptability of the intervention was very high indicating high feasibility with good design. The qualitative findings also supported the quantitative findings where both participants and counselors accepted and were satisfied with the structure and contents of the package. This study revealed that providing an inclusive six-week social selfvalue package for HIV-infected Nepali people appears to be feasible. Its effect on empowerment intervention will be measured by a randomized controlled trial. [ABSTRACT FROM AUTHOR]

Improving quality of life (QOL) for HIV-infected individuals is an important objective of HIV care, given the considerable physical and emotional burden associated with living with HIV. Although worse QOL has been associated with depression, no research has quantified the potential of improvement in depression to prospectively improve QOL among HIV-infected adults. We analyzed data from 115 HIV-infected adults with depression enrolled in a randomized controlled trial to evaluate the effectiveness of improved depression care on antiretroviral drug adherence. Improvement in depression, the exposure of interest, was defined as the relative change in depression at six months compared to baseline and categorized as full response (≥50% improvement), partial response (25–49% improvement), and no response (<25% improvement). Multivariable linear regression was used to investigate the relationship between improvement in depression and four continuous measures of QOL at six months: physical QOL, mental QOL, HIV symptoms, and fatigue intensity. In multivariable analyses, physical QOL was higher among partial responders (mean difference [MD] = 2.51, 95% CI: −1.51, 6.54) and full responders (MD = 3.68, 95% CI: −0.36, 7.72) compared to individuals who did not respond. Mental QOL was an average of 4.01 points higher (95% CI: −1.01, 9.03) among partial responders and 14.34 points higher (95% CI: 9.42, 19.25) among full responders. HIV symptoms were lower for partial responders (MD = −0.69; 95% CI: −1.69, 0.30) and full responders (MD = −1.51; 95% CI: −2.50, −0.53). Fatigue intensity was also lower for partial responders (MD = −0.94; 95% CI: −1.94, 0.07) and full responders (MD = −3.00; 95% CI: −3.98, −2.02). Among HIV-infected adults with depression, improving access to high-quality depression treatment may also improve important QOL outcomes. [ABSTRACT FROM AUTHOR]

The current study examined the efficacy of a web-based intervention (WBI; Avanti) on symptoms of depression and well-being for patients diagnosed with HIV. A two-armed randomized trial recruited patients on antiretroviral therapy (ART) at an outpatient clinic. Thirty-six patients were allocated to Avanti and 31 patients to a control group. Primary outcomes were symptoms of depression and subjective well-being (SWB), and secondary outcomes included life satisfaction and affect balance. Paired tests showed that only patients following Avanti had significant improvements in SWB by 3 months as well as affect balance. No significant differences between groups were detected in any of the outcome parameters at baseline after 3 months, as expected from group size and variability in the parameters. However, time since HIV diagnosis and ART initiation moderated the effects of Avanti. In conclusion, our data show that patients with HIV infection may benefit from a WBI in adjunct to medical treatment. [ABSTRACT FROM PUBLISHER]

Stress is implicated in the pathogenesis and progression of HIV. The Transcendental Meditation (TM) is a behavioral stress reduction program that incorporates mind–body approach, and has demonstrated effectiveness in improving outcomes via stress reduction. We evaluated the feasibility of implementing TM and its effects on outcomes in persons with HIV. In this community-based single blinded Phase-I, randomized controlled trial, outcomes (psychological and physiological stress, immune activation, generic and HIV-specific health-related quality of life, depression and quality of well-being) were assessed at baseline and at six months, and were compared using parametric and nonparametric tests. Twenty-two persons with HIV were equally randomized to TM intervention or healthy eating (HE) education control group. Retention was 100% in TM group and 91% in HE control group. The TM group exhibited significant improvement in vitality. Significant between group differences were observed for generic and HIV-specific health-related quality of life. Small sample size may possibly limit the ability to observe significant differences in some outcomes. TM stress reduction intervention in community dwelling adults with HIV is viable and can enhance health-related quality of life. Further research with large sample and longer follow-up is needed to validate our results. [ABSTRACT FROM PUBLISHER]

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]

Women working in China's entertainment industry are at increased risk of acquiring or transmitting HIV/sexually transmitted infections (STIs). Efforts to develop effective risk-reduction interventions for female entertainment workers (FEWs) remain limited. We conducted a randomized controlled trial of a theory-based risk-reduction intervention among FEWs in Shanghai. The intervention condition consisted of small group, peer-assisted sessions integrating information-motivation-behavioral skills training with social influences of behavior change. The control condition was an attention-matched HIV, health education, and counseling. At three-month post-intervention, participants in the intervention condition reported greater reductions in unprotected sex with a stable partner than participants in the control condition. However, participants in the control condition reported greater reductions in unprotected sex with a non-stable partner than participants in the intervention condition. Some aspects of the study design may have diluted the effects of the intervention. Future intervention studies need to pay more attention to social influences of behavior change and the particular challenges of risk-reduction with stable partner(s). [ABSTRACT FROM AUTHOR]

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]