Evaluating the Role of Family Context Within a Randomized Adolescent HIV-Risk Prevention Trial.
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ABSTRACT:
SUBMITTER: Barker DH
PROVIDER: S-EPMC6746402 | biostudies-literature | 2019 May
REPOSITORIES: biostudies-literature
Publications
Evaluating the Role of Family Context Within a Randomized Adolescent HIV-Risk Prevention Trial.
Barker David H DH Hadley Wendy W McGee Heather H Donenberg Geri R GR DiClemente Ralph J RJ Brown Larry K LK
AIDS and behavior 20190501 5
Project STYLE is a multi-site 3-arm RCT comparing family-based, adolescent-only, and general health promotion interventions with 721 adolescents in mental health treatment. This study reports 12-month outcomes for family context and sexual risk behaviors, and explores the role of baseline family context in modifying treatment response. Using the full sample, there were sustained benefits for parent-reported sexual communication (d = 0.28), and adolescent-reported parental monitoring (d = 0.24), ...[more]
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Project description:Adolescents and young people account for 40% of all new HIV infections each year, with South Africa one of the hardest hit countries, and having the largest population of people living with HIV. Although adolescent HIV prevention has been delivered through diverse modalities in South Africa, and although family-based approaches for adolescent HIV prevention have great potential for highly affected settings such as South Africa, there is a scarcity of empirically tested family-based adolescent HIV preventive interventions in this setting. We therefore conducted focus groups and in-depth interviews with key informants including clinicians, researchers, and other individuals representing organizations providing HIV and related health services to adolescents and parents (N = 82). We explored family perspectives and interactions around topics such as communication about sex, HIV, and relationships. Participants described aspects of family interactions that presented both challenges and opportunities for family-based adolescent HIV prevention. Parent-child communication on sexual topics were taboo, with these conversations perceived by some adults as an invitation for children to engage in HIV risk behavior. Parents experienced social sanctions for discussing sex and adolescents who asked about sex were often viewed as disrespectful and needing discipline. However, participants also identified context-appropriate strategies for addressing family challenges around HIV prevention including family meetings, communal parenting, building efficacy around parent-adolescent communication around sexual topics, and the need to strengthen family bonding and positive parenting. Findings indicate the need for a family intervention and identify strategies for development of family-based interventions for adolescent HIV prevention. These findings will inform design of a family intervention to be tested in a randomized pilot trial (ClinicalTrials.gov #NCT02432352).
| S-EPMC4828610 | biostudies-literature
Project description: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.
| S-EPMC4228374 | biostudies-literature
Project description:Obtaining the definitive data necessary to determine the safety and efficacy of using antiretroviral treatment (ART) to reduce the sexual transmission of HIV in heterosexual couples encountered an array of ethical challenges that threatened to compromise HIV Prevention Trials Network (HPTN) 052, the multinational clinical trial addressing this issue that has profound public health implications.To describe and analyze the major ethical challenges faced in HPTN 052.The ethical issues and modifications of HPTN 052 in response to these issues were cataloged by the principal investigator, the lead coordinator, and the ethicist working on the trial. The major ethical issues that were unique to the trial were then described and analyzed in light of the published literature as well as guidances and policies. The ethical challenges that must be addressed in many clinical trials, such as those related to obtaining informed consent and making provisions for ancillary care, are not described.When HPTN 052 was being designed, ethical questions emerged related to the relevance of the research question itself given data from observational research and a range of beliefs about the appropriate means of preventing and treating HIV infection and AIDS. Furthermore, ethical challenges were faced regarding site selection since there was a scientific need to conduct the research in settings where HIV incidence was high, but alternatives to study participation should be available. As in most HIV-prevention research, ethical questions surrounded the determination of the appropriate prevention package for all of those enrolled. During the course of the trial, guidance documents and policies emerged that were of direct relevance to the research questions, calling for a balancing of concerns for the research subjects and trial integrity. When the study results were made public, there was a need to ensure access to the treatment shown to be effective that in some cases differed from the guidelines used at the sites where the research was being conducted. In addition, questions were raised about whether there was an obligation to notify subjects about 'unlinked' transmissions of HIV, that is, infections acquired from someone other than the designated sexual partner enrolled in the study.The ethical issues described are limited to those discerned by the authors and not those of other stakeholders who may have identified additional issues or had a different perspective in analyzing them.Understanding the ethical challenges faced in HPTN 052 promises to inform the design and conduct of future complex, long-term clinical trials aimed at addressing critical scientific and public health questions, where data and practice patterns emerge over the course of the trial.
| S-EPMC3486723 | biostudies-other
Project description:ContextCost-effective, scalable programs are urgently needed in countries deeply affected by HIV.MethodsThis parallel-group RCT was conducted in four secondary schools in Mbarara, Uganda. Participants were 12 years and older, reported past-year computer or Internet use, and provided informed caregiver permission and youth assent. The intervention, CyberSenga, was a five-hour online healthy sexuality program. Half of the intervention group was further randomized to receive a booster at four-months post-intervention. The control arm received 'treatment as usual' (i.e., school-delivered sexuality programming). The main outcome measures were: 1) condom use and 2) abstinence in the past three months at six-months' post-intervention. Secondary outcomes were: 1) condom use and 2) abstinence at three-month's post-intervention; and 6-month outcomes by booster exposure. Analyses were intention to treat.ResultsAll 416 eligible youth were invited to participate, 88% (n = 366) of whom enrolled. Participants were randomized to the intervention (n = 183) or control (n = 183) arm; 91 intervention participants were further randomized to the booster. No statistically significant results were noted among the main outcomes. Among the secondary outcomes: At three-month follow-up, trends suggested that intervention participants (81%) were more likely to be abstinent than control participants (74%; p = 0.08), and this was particularly true among youth who were abstinent at baseline (88% vs. 77%; p = 0.02). At six-month follow-up, those in the booster group (80%) reported higher rates of abstinence than youth in the intervention, no booster (57%) and control (55%) groups (p = 0.15); they also reported lower rates of unprotected sex (5%) compared to youth in the intervention, no booster (24%) and control (21%) groups (p = 0.21) among youth sexually active at baseline.ConclusionsThe CyberSenga program may affect HIV preventive behavior among abstinent youth in the short term and, with the booster, may also promote HIV preventive behavior among sexually active youth in the longer term.Trial registrationNCT00906178.
| S-EPMC3743833 | biostudies-literature
Project description:BackgroundAs HIV infection continues unabated, there is a need for effective interventions targeting at-risk men who have sex with men (MSM). Engaging MSM online where they meet sexual partners is critical for HIV prevention efforts.MethodsA randomized controlled trial (RCT) conducted online among U.S. MSM recruited from several gay sexual networking websites assessed the impact of 2 HIV prevention videos and an HIV prevention webpage compared to a control condition for the study outcomes HIV testing, serostatus disclosure, and unprotected anal intercourse (UAI) at 60-day follow-up. Video conditions were pooled due to reduced power from low retention (53%, n = 1,631). No participant incentives were provided.Principal findingsFollow-up was completed by 1,631 (53%) of 3,092 eligible men. In the 60 days after the intervention, men in the pooled video condition were significantly more likely than men in the control to report full serostatus disclosure ('asked and told') with their last sexual partner (OR 1.32, 95% CI 1.01-1.74). Comparing baseline to follow-up, HIV-negative men in the pooled video (OR 0.70, 95% CI 0.54-0.91) and webpage condition (OR 0.43, 95% CI 0.25-0.72) significantly reduced UAI at follow-up. HIV-positive men in the pooled video condition significantly reduced UAI (OR 0.38, 95% CI 0.20-0.67) and serodiscordant UAI (OR 0.53, 95% CI 0.28-0.96) at follow-up.Conclusions/significanceFindings from this online RCT of MSM recruited from sexual networking websites suggest that a low cost, brief digital media intervention designed to engage critical thinking can increase HIV disclosure to sexual partners and decrease sexual risk. Effective, brief HIV prevention interventions featuring digital media that are made widely available may serve as a complementary part of an overall behavioral and biomedical strategy for reducing sexual risk by addressing the specific needs and circumstances of the target population, and by changing individual knowledge, motivations, and community norms.Trial registrationClinicalTrials.gov NCT00649701.
| S-EPMC3462792 | biostudies-literature
Project description:ObjectiveThis study aimed to evaluate the effectiveness of three levels of exercise on weight regain subsequent to clinically meaningful weight loss (WL).MethodsAdults with overweight or obesity (n = 298) initiated a 3-month behavioral WL intervention, which included reduced energy intake, increased exercise, and weekly behavioral counseling. Participants achieving ≥5% WL (n = 235) began a 12-month behavioral WL maintenance intervention and were randomized to 150 min/wk (n = 76), 225 min/wk (n = 80), or 300 min/wk (n = 79) of partially supervised moderate-to-vigorous-intensity exercise.ResultsParticipants randomized to 150, 225, and 300 minutes of exercise completed 129 ± 30, 153 ± 49 and 179 ± 62 min/wk of exercise (supervised + unsupervised), respectively. Mean WL at 3 months (9.5 ± 3.1 kg) was similar across randomized groups (P = 0.68). Weight change across 12 months was 1.1 ± 6.5 kg, 3.2 ± 5.7 kg, and 2.8 ± 6.9 kg in the 150, 225, and 300 min/wk groups, respectively. Intent-to-treat analysis revealed no significant overall trend across the three treatment groups (P = 0.09), effects for group (P = 0.08), or sex (P = 0.21).ConclusionsThis study found no evidence for an association between the volume of moderate-to-vigorous-intensity exercise and weight regain across 12 months following clinically relevant WL. Further, results suggest that exercise volumes lower than those currently recommended for WL maintenance, when completed in conjunction with a behavioral weight-maintenance intervention, may minimize weight regain over 12 months.
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Project description:The purpose of the FABO-study is to evaluate the effect of family-based behavioral social facilitation treatment (FBSFT), designed to target children's family and social support networks to enhance weight loss outcomes, compared to the standard treatment (treatment as usual, TAU) given to children and adolescents with obesity in a routine clinical practice.Randomized controlled trial (RCT), in which families (n?=?120) are recruited from the children and adolescents (ages 6-18 years) referred to the Obesity Outpatient Clinic (OOC), Haukeland University Hospital, Norway. Criteria for admission to the OOC are BMI above the International Obesity Task Force (IOTF) cut-off???35, or IOTF???30 with obesity related co-morbidity. Families are randomized to receive FBSFT immediately or following one year of TAU. All participants receive a multidisciplinary assessment. For TAU this assessment results in a plan and a contract for chancing specific lifestyle behaviors. Thereafter each family participates in monthly counselling sessions with their primary health care nurse to work on implementing these goals, including measuring their weight change, and also meet every third month for sessions at the OOC. In FBSFT, following assessment, families participate in 17 weekly sessions at the OOC, in which each family works on changing lifestyle behaviors using a structured cognitive-behavioral, socio-ecological approach targeting both parents and children with strategies for behavioral maintenance and sustainable weight change. Outcome variables include body mass index (BMI; kg/m2), BMI standard deviation score (SDS) and percentage above the IOTF definition of overweight, waist-circumference, body composition (bioelectric impedance (BIA) and dual-X-ray-absorptiometry (DXA)), blood tests, blood pressure, activity/inactivity and sleep pattern (measured by accelerometer), as well as questionnaires measuring depression, general psychological symptomatology, self-esteem, disturbed eating and eating disorder symptoms. Finally, barriers to treatment and parenting styles are measured via questionnaires.This is the first systematic application of FBSFT in the treatment of obesity among youth in Norway. The study gives an opportunity to evaluate the effect of FBSFT implemented in routine clinical practice across a range of youth with severe obesity.ClinicalTrails.gov NCT02687516 . Registered 16th of February, 2016.
| S-EPMC5073413 | biostudies-literature
Project description:BackgroundDigital HIV interventions (DHI) have been efficacious in reducing sexual risk behaviors among sexual minority populations, yet challenges in promoting and sustaining users' engagement in DHI persist. Understanding the correlates of DHI engagement and their impact on HIV-related outcomes remains a priority. This study used data from a DHI (myDEx) designed to promote HIV prevention behaviors among single young men who have sex with men (YMSM; ages 18-24 years) seeking partners online.ObjectiveThe goal of this study is to conduct a secondary analysis of the myDex project data to examine whether YMSM's online behaviors (eg, online partner-seeking behaviors and motivations) are linked to participants' engagement (ie, the number of log-ins and the number of sessions viewed).MethodsWe recruited 180 YMSM who were randomized into either myDEx arm or attention-control arm using a stratified 2:1 block randomization. In the myDEx arm, we had 120 YMSM who had access to the 6-session intervention content over a 3-month period. We used Poisson regressions to assess the association between YMSM's baseline characteristics on their DHI engagement. We then examined the association between the participants' engagement and their self-reported changes in HIV-related outcomes at the 3-month follow-up.ResultsThe mean number of log-ins was 5.44 (range 2-14), and the number of sessions viewed was 6.93 (range 0-22) across the 3-month trial period. In multivariable models, the number of log-ins was positively associated with high education attainment (estimated Poisson regression coefficient [β]=.22; P=.045). The number of sessions viewed was associated with several baseline characteristics, including the greater number of sessions viewed among non-Hispanic YMSM (β=.27; P=.002), higher education attainment (β=.22; P=.003), higher perceived usefulness of online dating for hookups (β=.13; P=.002) and perceived loneliness (β=.06; P=.004), as well as lower experienced online discrimination (β=-.01; P=.007) and limerence (β=-.02; P=.004). The number of sessions viewed was negatively associated with changes in internalized homophobia (β=-.06; P<.001) and with changes in perceived usefulness of online dating for hookups (β=-.20; P<.001). There were no significant associations between the number of log-ins and changes in the participants' behaviors at the 90-day follow-up.ConclusionsDHI engagement is linked to participants' sociodemographic and online behaviors. Given the importance of intervention engagement in the intervention's effectiveness, DHIs with personalized intervention components that consider the individuals' differences could increase the overall engagement and efficacy of DHIs.Trial registrationClinicalTrials.gov NCT02842060; https://clinicaltrials.gov/ct2/show/NCT02842060.
| S-EPMC9274398 | biostudies-literature
Project description:BackgroundAmong countries in sub-Saharan Africa, Zambia has one of the highest incidences of HIV. Adolescent girls and young women (AGYW) are a particularly affected group because of their social and economic vulnerability.ObjectiveThe goal of this study is to test a multilevel package of interventions at the community and health system levels in Zambia in order to connect AGYW with a source of regular care, which will in turn allow for sustainable, successful implementation of regular HIV testing and adherence to antiretroviral treatment.MethodsWe will adapt prior tools to create the SHIELD (Support for HIV Integrated Education, Linkages to Care, and Destigmatization) intervention to educate and empower Zambian AGYW of 10-24 years of age and their families and to create community-based youth clubs to foster peer support. We will also develop integrated wellness care clinics to offer a youth-friendly environment that provides tailored clinical services. We will perform formative research, including focus groups and in-depth interviews, among AGYW, caregivers, and stakeholders to help inform the development and tailoring of the interventions. A cluster-randomized controlled trial will be implemented in Lusaka, with six clinic catchment areas randomized into three groups: zones with integrated wellness care clinics and SHIELD intervention, zones with only SHIELD intervention, and control zones with no intervention. We will assess HIV testing among the HIV-negative or unknown (HIV-/u) cohort, and retention in care along with viral load suppression will be evaluated in the HIV-positive (HIV+) cohort. We will use in-depth interviews and surveys to collect staff and stakeholder feedback after the trial. Cost-effectiveness of the interventions and return-on-investment impacts will be quantified using a microsimulation model.ResultsInterim results are expected in 2021, and the final results are expected in 2022. If this multilevel intervention is successful in establishing a comprehensive care continuum for HIV-affected AGYW, the Zambian Ministry of Health may advocate for expansion to additional settings to support national scale-up.ConclusionsThis integrated service delivery model can also be a platform to implement additional preventive services, so HIV-/u and HIV+ AGYW can receive comprehensive, integrated services.Trial registrationClinicalTrials.gov NCT03995953; https://clinicaltrials.gov/ct2/show/NCT03995953.International registered report identifier (irrid)PRR1-10.2196/15314.
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Project description:Co-infection with HIV and hepatitis C virus (HCV) results in a threefold increase in relative risk of progression to end stage liver disease and cirrhosis compared to HCV alone. Although curative treatments exist, less than one quarter of people with HCV are linked to care, and even fewer have received treatment. The Care2Cure study is a single-blinded, randomized controlled trial to improve the HCV care continuum among people co-infected with HIV. This ongoing study was designed to test whether a nurse case management intervention can (i) improve linkage to HCV care and (ii) decrease time to HCV treatment initiation among 70 adults co-infected with HIV who are not engaged in HCV care. The intervention is informed by the Andersen Behavioral Model of Health Services Use and consists of nurse-initiated referral, strengths-based education, patient navigation, appointment reminders, and care coordination for drug-drug interactions in the setting of HIV primary care. Validated instruments are used to measure participant characteristics including HCV knowledge, substance use, and depression. The primary outcome is linkage to HCV care (yes/no) within 60 days. In this protocol paper, we describe the first clinical trial to examine the effects of a nurse case management intervention to improve the HCV care continuum among people co-infected with HIV/HCV in the era of all-oral HCV treatment. We describe our work in progress, challenges encountered, and strategies to engage this hard-to-reach population.
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