Search

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]

Poor participant adherence to treatment may contribute to lack of impact in some biomedical HIV prevention trials. This qualitative study explored adherence in a randomized controlled trial of herpes suppressive therapy to reduce HIV acquisition and infectivity among 1305 Tanzanian women. The trial found participants completed 72% of visits on treatment; 52-56% of women on treatment had ≥ 90% adherence by pill count estimate; and between six and nine months 30/86 (35%) of urine samples from acyclovir recipients tested acyclovir negative, and 7/86 (8%) from placebo recipients tested acyclovir positive. Twenty in-depth interviews (IDIs) were conducted after 30 months with respondents randomly selected from “acyclovir negative” acyclovir recipients and “acyclovir positive” placebo recipients, or by preliminary pill count adherence categories (“under users,” “good users,” and “over users”). Almost all respondents reported appropriate adherence and positive trial attitudes, e.g., trusting staff, appreciating services, perceiving pills as beneficial. Fourteen understood placebo use, and six understood the trial purpose. Notably, 5/9 acyclovir recipients and 1/11 placebo recipients believed their pills had treated pre-existing sexually transmitted infections. Limited understanding did not negatively affect reported adherence. Reported adherence problems usually related to illness, travel, and/or family obligations (e.g., husband's disapproval). “Acyclovir positive” placebo recipients denied taking other participants' pills. The IDIs also did not resolve discrepant reports of pill loss or theft. Biomedical HIV interventions often have strong behavioral components that require close attention during intervention development, trial design, and process and impact evaluation. This study identified topics which warrant further consideration, including: information reinforcement and comprehension assessment throughout a trial for long-term participant understanding; involving partners in adherence promotion activities; strategizing with participants to maintain adherence during familial illnesses or other crises; and close monitoring, identification, and follow-up of (1) individuals with discrepant biological tests, and (2) other sources of the treatment in the trial area. Methodological research is also needed to improve adherence measures. [ABSTRACT FROM AUTHOR]

We conducted a randomized controlled trial of a sexual risk-reduction intervention targeting non-injection drug users (NIDUs) and members of their drug-use/sexual networks (N=270). The intervention was based primarily on the social-influencing approach, and was delivered in four sessions. Sexual risk behaviors were examined at baseline, and 3, 6, 9, and 12 months after the completion of the intervention using the vaginal equivalent episodes (VEE), a weighted sexual risk behavior index. VEE scores decreased in both the active and control conditions in the first six months post-intervention and continued to decline in the control group. However, in the active condition, VEE scores increased after the nine-month assessment and approached baseline levels by the 12-month assessment. There was no evidence of significant differences in high-risk sexual behaviors between the intervention and control conditions. Future studies are needed to improve behavioral interventions in this population. [ABSTRACT FROM AUTHOR]

Background. Depression is highly prevalent among HIV-infected injection drug users (IDUs) and has been associated with poor adherence to antiretroviral therapy and increased morbidity and mortality. Factors associated with changes in depressive symptoms among this group receiving antiretroviral treatment that have not been extensively evaluated. Methods. This post-hoc analysis of prospective clinical trial analyzes the factors associated with changes in depressive symptomatology using the Center for Epidemiologic Studies of Depression Scale (CES-D) among HIV-infected IDUs enrolled in a prospective, six months randomized controlled trial of directly administered antiretroviral therapy (DAART) versus self-administered therapy. Results. Of the 127 evaluable IDUs enrolled in the study, 89 subjects (70%) had complete six-month follow-up data. Of these, 58 (63%) met baseline criteria for severe or major depressive disorder (MDD) using the CES-D. CES-D scores improved significantly from baseline to six months overall for the 89 subjects (p=0.01) and for the 58 who had MDD with six-month data (p=0.001). Using multiple regression, an improvement in CES-D score was independently associated with: (1) increase in CD4 count; (2) increase in adherence; (3) non-Caucasian race; and (4) older age. Worsening in CES-D score was associated with: (1) increase in HIV-1 RNA levels; (2) homelessness; (3) poor self-efficacy; (4) active drug use; and (5) male gender. Factors not correlated with changes in CES-D were receipt of DAART, engagement in drug treatment, use of antidepressant medication, and employment. Using generalized estimating equation modeling, factors that remained positively associated with improvements in CES-D score were absence of drug use at six months, having housing, higher self-efficacy, increase in CD4 count and increases in adherence. Conclusion. Improvements in depressive symptoms could occur with improvement of alterable factors that are associated with strengthening adherence such as linkages to case management, mental health and substance abuse treatment services as well as through enhancement of social stabilization factors through social support and supportive housing. [ABSTRACT FROM AUTHOR]

At the time of this writing, no randomized controlled trial (RCT) of an intervention to reduce unsafe sex among Latino gay and bisexual men (LGBM) had been published. We report the results of an RCT conducted in New York City in which 180 LGBM were assigned either to an intervention developed specifically for this population or to a wait-list control group. The intervention was based on empowerment theory and used factors identified in prior research as determinants of unsafe sex. By eligibility criteria, all men had engaged in unprotected anal intercourse (UAI) within two months of the baseline assessment. At first (two months) and second (six months later) follow-up assessments, approximately half of the men in the experimental group reported no UAI. Yet, a similar proportion of the control group also reported no UAI. Baseline data indicate that although the men had been the subject of social oppression and sexual prejudice (homophobia), they did not feel disempowered, externally controlled or fatalistic, and they reported self-efficacy and intentionality to enact safer sex. Lessons learned are discussed, as well as notes of caution for future research employing a similar conceptual framework. [ABSTRACT FROM AUTHOR]

Objective. Post-exposure prophylaxis (PEP) is recommended for the management of sexual HIV-risk exposure. However, a high percentage of exposed patients discontinue both their 28-day prophylaxis course before 15 days and HIV testing follow-up before M3. The objective of this study is to assess the efficacy of a counseling intervention in enhancing both adherence to PEP and HIV testing follow-up. Methods. Between 1 June 2004 and 31 December 2005, 54 patients exposed to sexual HIV-risk exposure were included in a multicenter, prospective, controlled, randomized trial, comparing a group receiving a counseling intervention in addition to traditional medical management (intervention group (IG), n=28) vs. a control group (CG, n=26). Patients in the IG received interactive counseling interventions focused on adherence to PEP and to HIV testing follow-up, led by specially trained nurses. The main outcome measures were proportion of patients achieving 100% adherence to PEP as evaluated on D15 by a self-completed patient questionnaire and on HIV testing on D45 and M3. Results. Groups were well balanced at baseline for age, sex, and circumstances of exposure. The proportion of 100% adherent patients to PEP was significantly higher in the IG compared to the CG (54% vs. 23%, p=0.036). Patients in the IG were more likely to complete the HIV testing follow-up at D45 (86% vs. 54%, p=0.023) and M3 (68% vs. 38%, p=0.056). Conclusions. This study suggests the effectiveness of a counseling program to enhance adherence to both PEP and HIV testing follow-up after sexual exposure. [ABSTRACT FROM AUTHOR]

Mobile populations are vulnerable to contracting HIV. The present study aims to evaluate the relative efficacy of the voluntary counseling and testing plus information dissemination (VCT-ID) approach versus the information dissemination (ID) approach for promoting HIV preventive behaviors in a mobile population, cross-border truck drivers. A total of 301 adult male cross-border truck drivers who self-reported having had sex with female sex workers (FSW) or non-regular sex partners (NRPs) in mainland China in the last 12 months were recruited and randomized into the VCT-ID intervention group (Group I) or ID control group (Group C). Anonymous structured questionnaires, administered through a computer-assisted method, were used to collect data. At the follow-up survey (about 8-9 weeks since the baseline survey), Group I participants, as compared to Group C participants, were more likely to be consistent condom users when having sex with FSW (85.5% versus 68.5%, p<0.05) and with NRP (54.8% versus 36.4%, p<0.1), more knowledgeable about HIV, and were less likely to have contracted sexually transmitted diseases (STD) in the last two months. The VCT-ID approach is shown to be more efficacious than the ID approach in promoting safer sex and HIV-related knowledge among local cross-border truck drivers. Feasibility of providing voluntary counseling and testing (VCT) services at locations which are convenient to the target population is demonstrated. It also shows that VCT services can be used as a means of HIV prevention. The findings of this study resulted in up-scaled VCT services for the local target population. [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]

The objective of the study was to present recruitment and retention findings for an Internet based HIV prevention trial evaluated using a randomized controlled design among 15-25-year-olds accessing a website on the Internet. We used a combination of automated electronic and personalized approaches to increase and diversify recruitment, verify participant eligibility and increase retention. We posted 3.5 million banner advertisements, 9354 individuals clicked on the advertisement, 8950 completed an eligibility screener and 3298 a baseline survey; we flagged 675 of these as suspicious and enrolled 2623 individuals. Of these, 2082 (79%) completed a follow-up at one-month and 1398 (53%) completed a two-month follow-up. This retention rate is the highest we have seen for an Internet-based HIV-prevention trial. Our procedures can be replicated in other trials. We stress the importance of using a combination of automated and personalized techniques to increase enrollment, verify eligibility and promote retention. [ABSTRACT FROM AUTHOR]

Mental illness is prevalent among people living with HIV (PLHIV) and hinders engagement in HIV care. While financial incentives are effective at improving mental health and retention in care, the specific effect of such incentives on the mental health of PLHIV lacks quantifiable evidence. We evaluated the impact of a three-arm randomized controlled trial of a financial incentive program on the mental health of adult antiretroviral therapy (ART) initiates in Tanzania. Participants were randomized 1:1:1 into one of two cash incentive (combined; provided monthly conditional on clinic attendance) or the control arm. We measured the prevalence of emotional distress, depression, and anxiety via a difference-in-differences model which quantifies changes in the outcomes by arm over time. Baseline prevalence of emotional distress, depression, and anxiety among the 530 participants (346 intervention, 184 control) was 23.8%, 26.6%, and 19.8%, respectively. The prevalence of these outcomes decreased substantially over the study period; additional benefit of the cash incentives was not detected. In conclusion, poor mental health was common although the prevalence declined rapidly during the first six months on ART. The cash incentives did not increase these improvements, however they may have indirect benefit by motivating early linkage to and retention in care. Clinical Trial Number: NCT03341556 [ABSTRACT FROM AUTHOR]

Parental HIV disclosure, where parents living with HIV (PLH) communicate their diagnosis to their children, is crucial for family communication. This study assessed intervention effects of a parental HIV disclosure intervention on psychosocial factors, focusing on child's age impact. Data from a randomized controlled trial involving 791 PLH in China were analyzed at baseline (W1), 6-month (W2), and 12-month follow-ups (W3). The study measured effects on psychosocial factors (HIV disclosure knowledge, outcome expectancy, action self-efficacy, and action planning) using the proportional latent change score method. Among PLH with children aged 6–9, the intervention yielded significant intervention effects on knowledge (β = 0.190, p = .004), action self-efficacy (β = 0.342, p = .001), and action planning (β = 0.389, p < .001) from W1 to W2. For PLH with children aged 10-12, the intervention significantly enhanced action self-efficacy (β = 0.162, p = .003) and action planning (β = 0.367, p = .001) from W1 to W2, but there was a reduction in perceived benefits (β = −0.175, p = 0.024) from W2 to W3. For PLH with children aged 13–15, significant intervention effects were observed on action planning, both from W1 to W2 (β = 0.251, p = .045) and from W2 to W3 (β = 0.321, p < .001). These findings highlight the importance of tailoring interventions to consider psychosocial factors and children's developmental stages to enhance HIV disclosure practices. [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]

Self-esteem is often negatively impacted by trauma. Low self-esteem has been related to significantly worse depression in people with HIV (PWH). This study explores whether the expression of words related to self-esteem during a 4-session augmented trauma writing intervention predicted post-traumatic stress, depressive symptoms, and health outcomes 6-months later. Ninety-five PWH completed four 30-minute augmented trauma writing sessions in the intervention arm of a randomized controlled trial. One augmented session was devoted to self-esteem. Two individuals coded trauma essays for number of self-esteem words. CD4+ and viral load data were collected, and the Davidson PTSD Scale and the Hamilton Depression Rating Scale were administered at baseline, one-, and six-month follow-up. Greater total self-esteem words were related to lower depressive symptoms at 6-months, controlling for depressive symptoms at study entry, age, race, and education (t(80) = −2.235, ß = −0.239, SE = 0.283, p < 0.05, 95% CI [−1.195, −.069). Total self-esteem words were not predictive of PTSD, viral load, or CD4+ at 6-months. Exploring self-esteem when writing about and processing a traumatic event could be an important mechanism for decreasing depressive symptoms among PWH. Research is needed to test augmented expressive writing interventions that support efforts to bolster self-esteem in PWH. [ABSTRACT FROM AUTHOR]

We aimed to examine the mediating role of alcohol use in the pathway from the interventions to depression and anxiety symptoms using data from a randomized controlled trial among people living with HIV (PWH) with hazardous alcohol use (n = 440) in Thai Nguyen, Vietnam. Participants were randomized into either a combined intervention (CoI), a brief intervention (BI) and a standard of care arm. Both interventions were based on cognitive behavioral therapy and motivational enhancement therapy. Alcohol use was measured as the percentage of days abstinent from alcohol in the last 30 days. Symptoms of depression and anxiety were measured with the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7 scales. Alcohol use was a significant mediator of the effects of two alcohol interventions on depression symptoms, but not anxiety symptoms. There were significant indirect effects via alcohol use of both interventions on depression symptoms at 12 months (CoI: mean difference (MD) = −0.134; 95%CI: −0.251, −0.035); (BI: MD = −0.141; 95%CI: −0.261, −0.038). There were no significant direct or total effects of the interventions on either symptoms at 12 months. Interventions with a dual focus on mental health and alcohol disorders are needed to determine optimal ways to tackle these common comorbidities among PWH. [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]

Disparities remain in HIV viral load (VL) suppression between people living with HIV (PLWH) who use cocaine and those who do not. It is not known how cannabis use affects VL suppression in PLWH who use cocaine. We evaluated the relationship between cannabis use and VL suppression among PLWH who use cocaine. We conducted a secondary data analysis of 119 baseline interviews from a randomized controlled trial in the Bronx, NY (6/2012 to 1/2017). Participants were adult PLWH prescribed antiretrovirals for ≥16 weeks, who endorsed imperfect antiretroviral adherence and used cocaine in the past 30-days. In bivariate and multivariable regression analyses, we examined how cannabis use, is associated with VL suppression among PLWH who use cocaine. Participants were a mean age of 50 years; most were male (64%) and non-Hispanic black (55%). Participants with VL suppression used cocaine less frequently than those with no VL suppression (p < 0.01); cannabis use was not significantly different. In regression analysis, compared with no use, daily/near-daily cannabis use was associated with VL suppression (aOR = 4.2, 95% CI: 1.1–16.6, p < 0.05). Less-frequent cannabis use was not associated with VL suppression. Further investigation is needed to understand how cannabis use impacts HIV outcomes among PLWH who use cocaine. [ABSTRACT FROM AUTHOR]

Mobile health (mHealth) has gained considerable interest recently due to its potential to improve health outcomes in developing countries with high outreach yet low costs. Several studies have explored the use of short message service (SMS) reminders to improve antiretroviral (ARV) retention and adherence, with mixed results. The majority of these studies has a quantitative nature and employs randomized designs, which do not provide further qualitative insights about other possible impacts of the messages. Based on the qualitative assessment of an SMS intervention in Burkina Faso, which complemented a (quantitative) Randomized Controlled Trial (RCT), we show that beyond the functional role of improving ARV retention and adherence, SMS messages can also play important symbolic roles in offering psychosocial support to people living with HIV (PLHIV) and improving their perception of life. Concomitantly, we show that sufficient (ICT) literacy skills cannot be taken for granted in resource-poor settings. Yet, regardless of (ICT) literacy skills, the symbolism of care was perceived. Furthermore, we highlight the importance of complementing quantitative evidence of mHealth interventions with qualitative assessments. [ABSTRACT FROM AUTHOR]

Despite a strong evidence on the negative association between HIV-related stigma and quality of life (QoL), few studies have examined the indirect effects of this relationship. This study aimed to examine the association between HIV-related stigma and QoL and the indirect effects of positive coping and perceived stress in people living with HIV and depressive symptoms (PLWHD). This study used baseline date from a randomized controlled trial. Structural equation model was used to examine the association between HIV-related stigma and QoL as well as the indirect effects of positive coping and perceived stress. Perceived and internalized stigma had negative direct (β = −0.14, p < 0.05) effect on QoL. Moreover, perceived and internalized stigma had indirect effects on QoL through decreased positive coping and increased perceived stress (β = −0.23, p < 0.001). Multilevel interventions to reduce perceived and internalized stigma and perceived stress as well as programs to enhance positive coping may improve QoL of PLWHD. Integrated interventions that both enhance positive coping and reduce perceived stress and stigma are potentially more effective in improving QoL than programs that focus on only one aspect of stigma reduction among PLWHD. [ABSTRACT FROM AUTHOR]

HCV co-infection is widespread among people living with HIV who use drugs (PLHWUD). However, HCV testing was inconsistently implemented among PLHWUD. The low infection awareness and mental health challenges together impede PLHWUD's treatment-seeking. The study used baseline data of a randomized controlled trial conducted in Vietnam. HCV infection status was collected through self-report and medical record review. A linear mixed-effects regression model was used to examine the relationships between PLHWUD's perceived barriers to seeking healthcare, their depressive symptoms, and the consistencies in HCV status reports. Among the 181 PLHWUD in the study, one-third (64; 35.4%) had inconsistent self-reports and medical records of HIV infection status. The agreement between the two records was fair (Kappa statistics = 0.43). PLHWUD with consistent HCV infection confirmed by both medical records and self-reports perceived lower levels of healthcare-seeking barriers than those with discrepant HCV reports (estimated difference = −1.59, SE = 0.71, P = 0.027). Depressive symptoms were significantly correlated with healthcare-seeking barriers among those with discrepant HCV results (estimate = 0.17, SE = 0.06, P = 0.007). There is an urgent need to extend HCV screening efforts and increase HCV awareness among PLHWUD. Explicit HCV result notification and integrated mental health support are recommended to facilitate patients' access to needed care. [ABSTRACT FROM AUTHOR]

The Respecting the Circle of Life (RCL) intervention is a comprehensive, skills-based sexual/reproductive health program shown to be effective for reducing sexual risk among American Indian (AI) adolescents (13-19 years of age). This paper seeks to identify critical program components of the RCL intervention for replication of impacts on condom use intention (CUI) when scaling to additional communities. RCL was tested among AI adolescents through a cluster randomized controlled trial (N = 267) embedded in an 8-day basketball camp. Data were collected at baseline, immediately post-camp, at 6 and 12 months post-camp. Previously established predictors of CUI that were statistically significantly impacted by RCL at the post-camp time point were tested as mediators of RCL impact on CUI. Condom use self-efficacy and response efficacy fully mediated the effect of RCL on CUI. The indirect path through condom use self-efficacy had the greatest effect on CUI, explaining 79% of the direct effect. When stratified by gender, there was only evidence of mediation among girls. Results indicate condom use self-efficacy and response efficacy are critical components of the RCL intervention for AI girls, and sexual/reproductive health programs should include practical skills training to improve these constructs to maximize intervention impact on CUI. [ABSTRACT FROM AUTHOR]

HIV self-test (HST) kits have been available for purchase directly by consumers since 2012. However, public health and prevention programs have been slow to adopt self-testing as a strategy for improving testing rates and regularity, in part due to concerns about its effects on the well-being of users and lack of follow-up. This study explored whether there were differences in several constructs related to well-being, including health-related quality of life, social support, health empowerment, and emotional distress, across those who used HSTs versus tested at a clinic over time. Data were drawn from a longitudinal randomized controlled trial exploring methods of encouraging HIV testing (clinic-based, regular home delivery of HSTs) and providing follow-up afterward. Results showed that using HST in a given month was not associated with changes in either distress or well-being that same month. Although social support was lower in months when HST was used (versus clinic-based testing), participants reported that engaging in other health behaviors (e.g., Healthy diet, exercise) were more important in months they used HST compared to testing in a clinic, suggesting that HST may empower MSM to begin making other lifestyle changes that could improve their health. [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]

A substantial body of literature has characterized how psychosocial factors, including HIV-related stigma and coping, are associated with HIV testing and HIV care utilization post-diagnosis. Less is known about if certain psychosocial characteristics pre-diagnosis may also predict linkage to care among individuals who receive an HIV-positive diagnosis. We examined if pre-diagnosis awareness/perception about HIV-related stigma and dispositional coping styles predicted linkage to HIV care within three months post-diagnosis with a secondary analysis of 604 patients from a randomized controlled trial (Sabes Study). Awareness/perception about HIV-related stigma, dispositional maladaptive and adaptive coping were measured before patients underwent an HIV test. Linkage to care was measured as receipt of care within three months of receiving the diagnosis. After adjusting for covariates, individuals who reported greater dispositional maladaptive coping pre-diagnosis had lower odds of linking to care, OR = 0.82, 95%CI [0.67, 1.00], p =.05. There was also a non-significant inverse association between dispositional adaptive coping pre-diagnosis and linkage to care. These preliminary data suggest the need for further longitudinal research and highlight the potential utility of pre-diagnosis psychosocial assessment and tailored counseling when providing positive HIV diagnosis results. [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]

HIV prevention interventions that reduce sexual risk behaviors among young Black men who have sex with men (YBMSM), the most severely affected population in the United States, are critical for reducing disparities in HIV infection. However, there are few theory-based sexual risk reduction interventions designed specifically for YBMSM. This study tested the applicability of the Integrated Behavioral Model (IBM), which theorizes that behavioral intentions mediate the relationship between psychosocial constructs and health behavior on condomless anal intercourse (CAI) among YBMSM. To test key constructs of the IBM, analyses were conducted with baseline data from the HealthMpowerment (HMP) randomized controlled trial. Logistic regression was used to examine the relationships between condom use self-efficacy, norms, attitudes, intentions, and environmental constraints, and CAI. Mediation analysis was conducted to determine if condom use intentions mediated the relationship between psychosocial constructs (i.e., condom use self-efficacy, norms, and attitudes) and CAI. Overall 55.7% reported one or more acts of CAI with a male partner in the past 3 months. Those who reported CAI in the 3 months prior to the baseline survey reported lower self-efficacy for condom use, lower condom use norms, more negative attitudes toward condom use, and lower condom use intentions at baseline than those who reported no CAI. In mediation analysis, the relationships between CAI and self-efficacy for condom use (estimated indirect effect = -0.004 (SE = 0.002)), condom use norms (-0.002 (SE = 0.001)) and attitudes toward condom use (-0.005 (SE = 0.002)) were mediated by condom use intentions. This study applied the IBM to sexual risk behavior among a sample of YBMSM. Results indicate that the relationships between condom use selfefficacy, norms, and attitudes, and CAI were mediated by condom use intentions. Future theoryinformed interventions should focus on increasing self-efficacy for condom use, condom use norms, attitudes toward condom use, and condom use intentions to reduce CAI among YBMSM. [ABSTRACT FROM AUTHOR]

Youth living with HIV have sub-optimal rates of adherence to antiretroviral therapy (ART). Mindfulness instruction interventions have shown promise for improving medication adherence, but the effects and mechanisms of these interventions are still being explored among people living with HIV, including youth. In the context of a randomized controlled trial of the efficacy of a Mindfulness-Based Stress Reduction (MBSR) program on ART adherence and viral suppression among youth living with HIV, we conducted 44 iterative, semi-structured, in-depth interviews with 20 study participants (13-24 years) recruited from clinics at two academic centers in Baltimore, Maryland. Interviews explored the social context and psychosocial dynamics of ART adherence in the context of the MBSR intervention, compared with those in a control arm. We employed thematic content analysis to systematically code and synthesize textual interview data. Participants’ challenges with ART adherence were often situated within an ongoing process of working to manage HIV as a stigmatized, chronic condition in addition to other intersecting social stigmas, inequalities, and stressors. Participation in the MBSR program and related group support allowed participants to non-judgmentally observe and accept difficult thoughts, feelings, and experiences associated with living with HIV and taking ART, which facilitated greater reported adherence. Mindfulness training may stimulate new perspectives and understanding, including greater self- and illness-acceptance among youth living with HIV, leading to improved HIV outcomes. [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]

There is growing evidence that mobile health (mHealth) approaches including short messaging service (SMS) can improve antiretroviral therapy (ART) adherence, but consensus is lacking regarding communication of HIV-related information. Most interventions to date have delivered SMS that do not overtly refer to HIV or ART in order to avoid risk of status disclosure. In formative work for an ongoing randomized controlled trial (RCT) evaluating one-way and two-way educational SMS for prevention of mother-to-child-transmission (PMTCT) adherence in Kenya, we conducted 10 focus group discussions (FGDs) with 87 HIV-infected peripartum women to determine desirability and preferred terminology of HIV-related content. SMS for the RCT were developed based on FGD findings. Roughly half of FGD participants supported receiving SMS containing overtly HIV-related terms, such as “HIV” and “medication”, citing desire for detailed educational messages about ART and PMTCT. Those opposed to overt content expressed concerns about confidentiality. Many participants argued that acceptability of HIV-related content depended on the recipient’s disclosure status and others’ access to her phone. Based on these findings, both covert and overt SMS were developed for the RCT and participants who owned their phone or had disclosed their HIV status to anyone with access to their phone were able to choose one of three options: (1) covert SMS only, (2) overt SMS only in response to HIV-related questions from the participant, (3) overt SMS routinely, initiated by the study. Of the 825 participants in the RCT, 94% were eligible to receive overt SMS. Of these, 66% opted to receive routine overt SMS and 10% to receive participant-initiated overt SMS. These findings show there may be interest in overt HIV-related information by SMS when risk of status disclosure is low, and support use of messaging strategies that allows participant choice in HIV-related content while protecting against undesired disclosure. [ABSTRACT FROM AUTHOR]

Antiretroviral therapy (ART) could curtail the HIV epidemic, but its impact is diminished by low uptake. We developed a peer navigation program to enhance engagement in HIV care, ART adherence, and behavioral prevention. In preparation for a randomized controlled trial, the program was piloted over four months at two primary health clinics in South Africa's North West Province. Newly diagnosed, HIV-positive clients met regularly with navigators to address barriers to care, adherence, and prevention. To assess program acceptability and feasibility and characterize the mechanisms of action, we surveyed 25 clients who completed navigation services and conducted interviews with 10 clients, four navigators, and five clinic providers. Clients expressed near universal approval for the program and were satisfied with the frequency of contact with navigators. HIV stigma emerged as a primary driver of barriers to care. Navigators helped clients overcome feelings of shame through education and by modeling how to live successfully with HIV. They addressed discrimination fears by helping clients disclose to trusted individuals. These actions, in turn, facilitated clients' care engagement, ART adherence, and HIV prevention efforts. The findings suggest peer navigation is a feasible approach with potential to maximize the impact of ART-based HIV treatment and prevention strategies. [ABSTRACT FROM AUTHOR]

Human immunodeficiency virus (HIV) testing is an important global prevention strategy but underutilized by local men who have sex with men (MSM). This study investigated the prevalence of behavioral intention to take up HIV testing (specific or any type), in the next six months among MSM who had not been tested for HIV in the last three years (never-testers) in Hong Kong. The data was based on 141 never-testers of 430 MSM who completed the anonymous baseline telephone survey of an ongoing randomized controlled trial from January 2015 to August 2015. Only 17.7% of them showed strong intention to take up any type of HIV testing in the next six months. Adjusted analysis showed that perceived benefit of HIV testing (adjusted odds ratio [AOR]: 1.29, 95% confidence interval [CI]: 1.01, 1.66), perceived psychological barriers of HIV testing (AOR: 0.85, 95%CI: 0.73, 1.00), and perceived self-efficacy in taking up HIV testing (AOR: 1.28, 95%CI: 1.07, 1.52) were significantly associated with behavioral intention to take up any HIV testing. Perceived cue to action from non-governmental organization staff was positively associated with a marginalp-value of 0.077 (AOR: 2.37, 95%CI: 0.97, 5.77). It is warranted to strengthen perceived benefit, remove psychological barriers, and increase perceived self-efficacy related to HIV testing. Innovative and effective health promotions are greatly needed to increase HIV testing coverage among never-testers. [ABSTRACT FROM PUBLISHER]