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33 result(s) for "Donenberg, Geri R."
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IMARA: A mother-daughter group randomized controlled trial to reduce sexually transmitted infections in Black/African-American adolescents
Black/African-American girls are infected with sexually transmitted infections (STIs) at higher rates than their White counterparts. This study tested the efficacy of IMARA, a mother-daughter psychosocial STI/HIV prevention program, on adolescent Black/African-American girls' incident STIs at 12 months in a 2-arm group randomized controlled trial. Black/African-American girls 14-18 years old and their primary female caregiver were eligible for the study. Girls provided urine samples to test for N. gonorrhoeae, C. trachomatis, and T. vaginalis infection at baseline and 12-months. Mother-daughter dyads were randomly assigned to IMARA (n = 118) or a time-matched health promotion control program (n = 81). Retention at 12-months was 86% with no difference across arms. Both interventions were delivered over two consecutive Saturdays totaling 12 hours. Girls who received IMARA were 43% less likely to contract a new STI in the 12-month post-intervention period compared with those in the health promotion control program (p = .011). A secondary follow-up intent-to-treat analysis provided additional support for the protective effect of IMARA, albeit with a similar magnitude of 37% (p = .014). Findings provide early evidence for IMARA's efficacy, such that IMARA protected against STIs at 12-months among adolescent Black/African-American girls. Future research should examine the mechanisms associated with reduced STIs.
Strengthening implementation science research to improve adolescent and young adult HIV-prevention and care in Sub-Saharan Africa: PATC3H-IN
Background Despite significant progress in HIV prevention and treatment, uptake of evidence-based interventions among adolescents and young adults (AYA), particularly in low- and middle-income countries (LMICs), remains low. Implementation research can optimize strategies to enhance reach, uptake, and equitable access to these innovations. The Prevention and Treatment through a Comprehensive Care Continuum for HIV-affected Adolescents in Resource-Constrained Settings Implementation Science Network (PATC 3 H-IN) leverages implementation science to strengthen the delivery and sustainability of evidence-based HIV prevention and care for AYA across six countries in sub-Saharan Africa. This paper outlines PATC 3 H-IN’s goals, summarizes the implementation science (IS) data that will be collected, and highlights the advantages of research networks in advancing science. Methods The PATC 3 H-IN builds on the existing PATC 3 H consortium to advance IS research targeting AYA in LMICs. The PATC 3 H-IN comprises eight Clinical Research Centers (CRCs) located in Nigeria, Uganda, Malawi, South Africa, Zambia, and Tanzania. Representatives from the CRCs were asked to provide information on the IS components of their proposed studies, including details on study populations, IS frameworks, outcomes, and strategies, mechanisms of change, effectiveness outcomes, and documentation of intervention adaptations. The reports from the CRCs were compared to identify opportunities for advancing science across study sites. Results The PATC 3 H-IN studies will enroll AYA aged 12–24 years, with some emphasizing key subpopulations, namely AYA living with HIV, sexual and gender minorities, and adolescent girls and young women. All PATC 3 H-IN studies will be guided by one or more implementation science frameworks and theories, with the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework most frequently cited ( n  = 4/8). Across the CRCs, 54 unique implementation strategies will be used, with community engagement being the most common. Several studies will document intervention adaptations, and all studies will collect a set of common data elements to facilitate secondary data analyses across projects. Conclusions The PATC 3 H-IN represents a significant contribution to advancing HIV prevention and care research for AYA in resource-constrained settings. Findings from PATC 3 H-IN will extend our understanding of IS in sub-Saharan Africa, a region particularly burdened by HIV, and for AYA who are traditionally under-represented in IS research. Clinical trial number Not Applicable.
A hybrid effectiveness implementation trial testing an HIV and STI prevention program for mother figures and their adolescent girls and young women delivered by peer leaders: ZAIMARA study protocol
Background Zambia is struggling to meet the 95-95-95 targets established by the Joint United Nations Programme on HIV/AIDS for adolescent girls and young women (AGYW), and HIV incidence remains high. The Zambian government has declared adolescent HIV prevention and sexual health as priorities, but new strategies are needed to facilitate HIV testing uptake among AGYW. Mother figures (MF), who are the center of Zambian families, may hold the key. The excessive burden on the healthcare workforce has impeded the implementation of effective HIV prevention programs. To sustain effective programs, implementation strategies are needed that reduce worker burnout and improve job satisfaction and employee retention. Task shifting to peer leader intervention delivery and attention to healthcare worker stress has the potential to strengthen and sustain program delivery. This study will test an intervention called ZAIMARA for AGYW and MF to improve HIV testing uptake and evaluate implementation outcomes when delivered by peer leaders. Methods This 2-arm individually randomized hybrid effectiveness-implementation trial will compare ZAIMARA to a health promotion (HP) program across five sites in Lusaka. We will enroll up to 650 dyads comprised of 15-19-year-old Zambian AGYW and their MF. Peer leaders randomized and trained to deliver ZAIMARA or HP will receive mental health distress screening and referral versus nutrition and exercise screening. AGYW-MF dyads will participate in a 2-day group workshop and complete 6-, 12-, 18-, and 24-month assessments. Peer leaders will complete 6- and 12-month assessments. Primary outcomes are HIV-testing uptake for AGYW and job retention for peer leaders at 6-months. Secondary outcomes include incident sexually transmitted infections, including HIV, uptake of pre-exposure prophylaxis, and safer sexual behavior at 12-, 18-, and 24-months. We will evaluate implementation outcomes and intervention costs. Discussion This study is poised to add a novel approach to HIV prevention among AGYW in Zambia and inform implementation considerations. ZAIMARA may provide a scalable solution to improve HIV testing and prevention practices for AGYW and identify features of implementation that strengthen sustainability. Findings will inform national HIV prevention strategies in Zambia and offer insights into the broader application of family-based interventions in similar low-resource settings globally. Trial registration ClinicalTrials.gov, NCT06503666, Registered on 10 July 2024.
Theater testing a sexual and reproductive health program for Latina teens and their female caregivers: a mixed methods study
Background Floreciendo is a sexual and reproductive health program for Latina teens (14–18 years) and their female caregivers adapted from the evidence-based IMARA intervention. We report on our experience theater testing Floreciendo during the preparation phase of the multiphase optimization strategy (MOST) framework. Floreciendo includes four two-hour sessions (i.e., intervention components). Our aims were to: (1) examine the preliminary acceptability, appropriateness, and feasibility of the intervention components, including the acceptability of the implementation plan (i.e., logistics, strategies), and (2) systematically report on curriculum modifications made based on findings. Methods Using a community-based participatory research approach, we theater tested the program at a community organization over one weekend with three teen-caregiver dyads ( n  = 6) using mixed methods. Immediately following the delivery of each intervention component, teens and caregivers completed surveys and engaged in feedback sessions. Observers ( n  = 8) and facilitators ( n  = 2) completed surveys, recorded activity start and end times, and participated in a post-program discussion. Survey item ratings were on four-point Likert scales, with higher scores indicating more favorable results. Feedback informed subsequent curriculum modifications, which were documented using the FRAME. Results We found high satisfaction with the intervention components among all surveyed ( n  = 16) and with the implementation plan among teens and caregivers ( n  = 6) (≥ 3.7/4.0). Teens and caregivers described sessions as “educational,” “motivating,” “interactive,” and “fun”; all (100%; n  = 6) reported that they would recommend the program to others. Teens and caregivers rated the appropriateness of the material and language/wording highly (4.0/4.0; n  = 6), although caregivers expressed difficulty understanding “passive communication” given translation difficulties. Feasibility was also rated highly across groups (≥ 3.8/4.0; n  = 16); 18% of activities were 10 + minutes longer than planned based on observer reports but the sessions overall remained within 2 min of the allotted time. We modified the intervention components based on the feedback received. For example, we moved discussions about sex to come later in the foundational session to increase participant comfort. Conclusions Findings offer preliminary evidence of Floreciendo’s acceptability, appropriateness, and feasibility. Theater testing is a valuable tool for intervention adaptation and FRAME is useful for tracking curriculum modifications over time. MOST researchers could consider theater testing while carrying out preparation-phase activities.
An individually randomized controlled trial of a mother-daughter HIV/STI prevention program for adolescent girls and young women in South Africa: IMARA-SA study protocol
Background South Africa has the world’s largest HIV epidemic, but South African adolescent girls and young women (AGYW) acquire HIV at twice the rate of and seroconvert on average 5–7 years earlier than their male peers. Female caregivers (FC) are an untapped resource for HIV/STI prevention in South Africa and offer a novel opportunity to strengthen AGYW prevention efforts. This study will evaluate the effectiveness and cost-effectiveness of an evidence-based mother-daughter HIV/STI prevention program tested in the United States and adapted for South Africa, I nformed M otivated A ware and R esponsible A dolescents and A dults (IMARA), to decrease STI incident infections and increase HIV testing and counseling (HTC) and PrEP uptake in AGYW. Methods This is a 2-arm individually randomized controlled trial comparing IMARA to a family-based control program matched in time and intensity with 525 15–19-year-old Black South African AGYW and their FC-dyads in Cape Town’s informal communities. AGYW will complete baseline, 6-, and 12-month assessments. Following randomization, AGYW-FC dyads will participate in a 2-day group workshop (total 10 h) that includes joint and separate mother and daughter activities. Primary outcomes are AGYW STI incidence, HTC uptake, and PrEP uptake at 6 months. Secondary outcomes are AGYW STI incidence, HTC uptake, and PrEP uptake at 12 months, sexual behavior (e.g., condom use, number of partners), HIV incidence, and ART/PrEP adherence and intervention cost-effectiveness. AGYW who test positive for a STI will receive free treatment at the study site. HIV positive participants will be referred to ART clinics. Discussion Primary prevention remains the most viable strategy to stem new STI and HIV transmissions. HIV and STI disparities go beyond individual level factors, and prevention packages that include supportive relationships (e.g., FC) may produce greater reductions in HIV-risk, improve HTC and PrEP uptake, and increase linkage, retention, and adherence to care. Reducing new HIV and STI infections among South African AGYW is global public health priority. Trial registration ClinicalTrials.gov Number NCT04758390 , accepted 02/16/2021.
Disseminating Evidence-Based Interventions for Adolescent HIV Treatment and Prevention in Sub-Saharan Africa
Over two-thirds of adolescents living with HIV worldwide reside in sub-Saharan Africa (SSA). Despite widespread availability and access to evidence-based HIV prevention and treatment, dissemination has been inadequate. This commentary distinguishes between implementation and dissemination, reflecting on the unique barriers to dissemination of evidence-based programs in SSA. We present a seven-strategy blueprint developed by United States Agency for International Development (USAID) that emphasizes targeted communication about research findings. Two case studies from the Adolescent HIV Implementation Science Alliance are presented to illustrate the value of planning for dissemination. We propose recommendations to strengthen dissemination recognizing that these may not be possible or appropriate in all situations, including developing a plan early in the process, engaging a dissemination technical team for support, the application of methodological rigor and theory to inform dissemination, active involvement of youth voices and digital tools to maximize message reach, and a keen recognition of evolving contexts and shifting priorities in order to nimbly tailor messages as needed.
Preparing to implement Floreciendo with Latina teens and their female caregivers: Integrating implementation science and the multiphase optimization strategy framework
Abstract Background Practical examples of studies integrating implementation science and the multiphase optimization strategy (MOST) framework are lacking. Floreciendo is a sexual and reproductive health program for Latina teens and their female caregivers, adapted from the IMARA evidence-based program. Purpose We prepared for delivering Floreciendo by developing an implementation plan to support the program’s adoption and sustainment. Methods Drawing on a community-based participatory research approach, we used qualitative methods to explore program logistics, implementation determinants and strategies, adoption, and sustainability. We positioned our study activities within the preparation phases of both the MOST and the EPIS frameworks. We conducted and rapidly analyzed seven focus group discussions—one with Latina teens (n = 9), one with female caregivers (n = 6), four with organizational staff (n = 32), and one with IMARA staff (n = 6)—and seven key informant interviews. Results Participants described community organizations as the preferred location for workshops in offering a “safe space.” They recommended workshop delivery on two days over separate weekends. Teens and caregivers requested relatable, bilingual Latina facilitators. Implementation barriers were raised (e.g. work conflicts) with strategies to address them (e.g. provide stipends). Organizational adoption was perceived as likely since the workshop addresses clients’ needs and fits with organizational values. Recommendations for sustainment included identifying funding opportunities specific to each organization. Conclusions Findings directly informed our immediate plans to optimize Floreciendo using the MOST framework and principles and our long-term goals for adoption and sustainability. Implementation science can strengthen studies using the MOST framework. Implementation science can enhance research conducted using the multiphase optimization strategy (MOST) framework. Lay Summary • Why was this study done? Floreciendo is a sexual and reproductive health program for Latina teens and their female caregivers. We researched how best to implement the program, including exploring what would support the program’s delivery, potential barriers we would face when delivering Floreciendo, and strategies we could use to help the program succeed. • What did we do? We worked as a team of community organizations, university researchers, Latina teens, female caregivers, and others experienced in sexual and Latina health. We integrated the phases of the EPIS framework (which supports implementation planning) with the MOST framework (which focuses on optimizing an intervention through decision-making based on real-world constraints). We rapidly analyzed seven focus groups and seven key-informant interviews. • What does this paper add? We provide a practical example of how researchers can develop an implementation plan while using the MOST framework. We learned about key considerations for implementing Floreciendo (e.g. where and when the program should take place, who should facilitate it, barriers we might face, and strategies to address them). We also gained perspectives on the program’s potential adoption within organizations and how we can support its continued delivery. We highlight the importance of partnerships between community stakeholders and researchers to achieve our goals. • What do the findings mean? Findings will play a key role in creating and implementing a program to support Latina teens over the long term. Our findings can also inform future studies that use the MOST framework. Graphical Abstract Graphical Abstract
The Combined Influence of Monitoring and Early Puberty on Disruptive Behavior Problems in African American Girls
Adolescent girls’ disruptive behavior problems (DBP) are associated with risk for other mental health challenges and legal system involvement. Existing literature suggests early pubertal timing and low maternal monitoring might confer risk for DBP; however, few studies examine the combined influence of these factors, particularly in samples at risk for both DBP and early pubertal timing. This longitudinal study examined whether perceived pubertal timing moderated the association between maternal monitoring and DBP in a treatment-seeking sample of 256 African American adolescent girls (ages 12–16) and their female caregivers. Hierarchical linear regression analyses demonstrated that pubertal timing moderated the association between maternal monitoring and DBP. For early-developing girls, maternal monitoring and DBP at 1-year were negatively associated. Maternal monitoring was not related to DBP at 1-year for on-time and later-developing girls. Findings suggest that maternal monitoring may be a more effective parenting practice for preventing DBP in early-developing girls as compared to their on-time and later-developing peers.HighlightsPubertal timing moderated the relation between monitoring and DBP in a treatment-seeking sample of African American girls.Maternal monitoring and DBP at 1-year were negatively related for early developers.Maternal monitoring was not related to DBP at 1-year for on-time/later developers.Maternal monitoring may be more effective for preventing DBP in early-developing girls as compared to their on-time and later-developing peers.
HIV-Risk Reduction with Juvenile Offenders on Probation
Youth involved in the juvenile justice system are at elevated risk for HIV as a result of high rates of sexual risk taking, substance use, mental health problems and sexually transmitted infections. Yet few HIV prevention programs exist for young offenders. This pilot study examined change in juvenile offenders’ sexual activity, drug/alcohol use, HIV testing and counseling, and theoretical mediators of risk taking following participation in preventing HIV/AIDS among teens (PHAT Life), an HIV-prevention program for teens on probation. Participants (N = 54) were 13–17 year-old arrested males and females remanded to a detention alternative setting. Youth participated in a uniquely tailored HIV prevention intervention and completed a baseline and 3-month follow up assessment of their HIV and substance use knowledge, attitudes, beliefs, and behaviors. At 3-month follow up, teens reported less alcohol use, more positive attitudes toward peers with HIV, greater ability to resist temptation to use substances, and for males, improved HIV prevention self-efficacy and peer norms supporting prevention. Teens were also more likely to seek HIV counseling and males were more likely to get tested for HIV. Effect sizes revealed moderate change in sexual behavior. Findings support PHAT Life as a promising intervention to reduce HIV-risk among youth in juvenile justice.
Childhood violence exposure and the development of sexual risk in low-income African American girls
Low-income, urban African American (AA) girls are at heightened risk for sexually transmitted infections (STIs), and violence exposure may be an important risk factor. AA girls (N = 177) from low-income communities in Chicago completed a 2-year longitudinal study of HIV-risk behavior involving five waves of data collection (ages 12–16 at baseline) and a sixth wave (ages 14–22) assessing lifetime trauma and victimization history. Childhood exposure to violence (CEV) represented reports of physical, sexual, or witnessed violence before age 12. Latent growth curve analysis examined CEV as a covariate of sexual experience, number of sexual partners, and inconsistent condom use trajectories. CEV was associated with greater sexual risk, although the pattern differed across the three outcomes. Overall, findings emphasize the need for early interventions to reduce sexual risk among low-income urban girls who have experienced violence. Efforts to address or prevent violence exposure may also reduce rates of STIs in this population.