Dataset Information

Efficacy of a group-based multimedia HIV prevention intervention for drug-involved women under community supervision: project WORTH.

ABSTRACT:

Importance

This study is designed to address the need for evidence-based HIV/STI prevention approaches for drug-involved women under criminal justice community supervision.

Objective

We tested the efficacy of a group-based traditional and multimedia HIV/STI prevention intervention (Project WORTH: Women on the Road to Health) among drug-involved women under community supervision.

Design, setting, participants, and intervention

We randomized 306 women recruited from community supervision settings to receive either: (1) a four-session traditional group-based HIV/STI prevention intervention (traditional WORTH); (2) a four-session multimedia group-based HIV/STI prevention intervention that covered the same content as traditional WORTH but was delivered in a computerized format; or (3) a four-session group-based Wellness Promotion intervention that served as an attention control condition. The study examined whether the traditional or multimedia WORTH intervention was more efficacious in reducing risks when compared to Wellness Promotion; and whether multimedia WORTH was more efficacious in reducing risks when compared to traditional WORTH.

Main outcomes and measures

Primary outcomes were assessed over the 12-month post-intervention period and included the number of unprotected sex acts, the proportion of protected sex acts, and consistent condom use. At baseline, 77% of participants reported unprotected vaginal or anal sex (n?=?237) and 63% (n?=?194) had multiple sex partners.

Results

Women assigned to traditional or multimedia WORTH were significantly more likely than women assigned to the control condition to report an increase in the proportion of protected sex acts (??=?0.10; 95% CI?=?0.02-0.18) and a decrease in the number of unprotected sex acts (IRR?=?0.72; 95% CI?=?0.57-0.90).

Conclusion and relevance

The promising effects of traditional and multimedia WORTH on increasing condom use and high participation rates suggest that WORTH may be scaled up to redress the concentrated epidemics of HIV/STIs among drug-involved women in the criminal justice system.

Trial registration

ClinicalTrials.gov NCT01784809.

SUBMITTER: El-Bassel N

PROVIDER: S-EPMC4221040 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Efficacy of a group-based multimedia HIV prevention intervention for drug-involved women under community supervision: project WORTH.

El-Bassel Nabila N Gilbert Louisa L Goddard-Eckrich Dawn D Chang Mingway M Wu Elwin E Hunt Tim T Epperson Matt M Shaw Stacey A SA Rowe Jessica J Almonte Maria M Witte Susan S

PloS one 20141105 11

<h4>Importance</h4>This study is designed to address the need for evidence-based HIV/STI prevention approaches for drug-involved women under criminal justice community supervision.<h4>Objective</h4>We tested the efficacy of a group-based traditional and multimedia HIV/STI prevention intervention (Project WORTH: Women on the Road to Health) among drug-involved women under community supervision.<h4>Design, setting, participants, and intervention</h4>We randomized 306 women recruited from community ...[more]

PMID: 25372149

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Project description:IntroductionPeople with experience of the criminal justice system typically have worse physical and mental health, lower levels of mental well-being and have less healthy lifestyles than the general population. Health trainers have worked with offenders in the community to provide support for lifestyle change, enhance mental well-being and signpost to appropriate services. There has been no rigorous evaluation of the effectiveness and cost-effectiveness of providing such community support. This study aims to determine the feasibility and acceptability of conducting a randomised trial and delivering a health trainer intervention to people receiving community supervision in the UK.Methods and analysisA multicentre, parallel, two-group randomised controlled trial recruiting 120 participants with 1:1 individual allocation to receive support from a health trainer and usual care or usual care alone, with mixed methods process evaluation. Participants receive community supervision from an offender manager in either a Community Rehabilitation Company or the National Probation Service. If they have served a custodial sentence, then they have to have been released for at least 2 months. The supervision period must have at least 7 months left at recruitment. Participants are interested in receiving support to change diet, physical activity, alcohol use and smoking and/or improve mental well-being. The primary outcome is mental well-being with secondary outcomes related to smoking, physical activity, alcohol consumption and diet. The primary outcome will inform sample size calculations for a definitive trial.Ethics and disseminationThe study has been approved by the Health and Care Research Wales Ethics Committee (REC reference 16/WA/0171). Dissemination will include publication of the intervention development process and findings for the stated outcomes, parallel process evaluation and economic evaluation in peer-reviewed journals. Results will also be disseminated to stakeholders and trial participants.Trial registration numbersISRCTN80475744; Pre-results.

Project description:ImportanceConcentrated epidemics of HIV and sexually transmitted infections (STIs) have persisted among Black women in community supervision programs (CSPs) in the United States. Accumulating research has highlighted the effectiveness of culturally tailored HIV/STI interventions for Black women; however, there is a dearth of such interventions for the large number of Black women in CSPs.ObjectiveTo determine the effectiveness of a 5-session culturally tailored group-based intervention (Empowering African-American Women on the Road to Health [E-WORTH]) with individualized computerized modules and streamlined HIV testing in reducing STIs and condomless sex vs a 1-session streamlined HIV testing control condition.Design, setting, and participantsThis randomized clinical trial was conducted from November 18, 2015, (first recruitment) to August 20, 2019 (last 12-month follow-up). Black women mandated to probation, parole, or alternative-to-incarceration programs in New York City who had a history of drug use were recruited and randomized to receive either E-WORTH or a streamlined HIV testing control condition. Both conditions were delivered by Black female staff at a large CSP. The analysis took an intention-to-treat approach.InterventionE-WORTH included a 1-hour individual HIV testing and orientation session and 4 weekly 90-minute group sessions. The control condition included one 30-minute session of HIV testing and information.Main outcomes and measuresPrimary outcomes were incidence of any STI (biologically assayed chlamydia, gonorrhea, and Trichomonas vaginalis) at the 12-month assessment and the number of condomless acts of vaginal or anal intercourse in the past 90 days during the 12-month period.ResultsA total of 352 participants who identified as Black or African American were enrolled, including 79 (22.5%) who also identified as Latinx. The mean (SD) age was 32.4 (11.0) years. A total of 172 participants (48.9%) were assigned to the E-WORTH condition, and 180 (51.1%) were assigned to the control condition. Compared with control participants, participants assigned to the E-WORTH condition had 54% lower odds of testing positive for any STI at the 12-month follow-up (odds ratio, 0.46; 95% CI, 0.25-0.88; P = .01) and reported 38% fewer acts of condomless vaginal or anal intercourse during the 12-month period (incidence rate ratio, 0.62; 95% CI, 0.39-0.97; P = .04).Conclusions and relevanceThe magnitudes of effects found across biological and behavioral outcomes in this randomized clinical trial indicate the feasibility and effectiveness of implementing E-WORTH in real-world CSPs. The findings lend further evidence to the promise of culturally tailored HIV/STI interventions for Black women.Trial registrationClinicalTrials.gov Identifier: NCT02391233.

Project description:ImportanceThe incidence of HIV infection among transgender women in the United States is extremely high, with young transgender women (YTW) at highest risk; condomless sex is the primary risk behavior for transmission. However, there are no published randomized clinical trials to date examining interventions to reduce sexual risk for HIV acquisition and transmission within this group.ObjectiveTo determine the efficacy of a culturally specific, empowerment-based, and group-delivered behavioral prevention intervention to reduce sexual risk for HIV acquisition and transmission in sexually active YTW aged 16 to 29 years.Design, setting, and participantsRandomized clinical efficacy trial of Project LifeSkills, a group-delivered, behavioral HIV prevention intervention, vs standard of care conducted among 190 sexually active YTW between March 26, 2012, and August 15, 2016, at community-based locations in Boston, Massachusetts, and Chicago, Illinois, to reduce sexual risk for HIV acquisition or transmission. Data analysis was by a modified intention-to-treat approach.InterventionsParticipants were randomized (approximately 2:2:1) to the LifeSkills intervention (n = 116), standard of care only (n = 74), or a diet and nutrition time- and attention-matched control (attention control) arm (n = 43). The attention control arm was dropped during active enrollment per the Data Safety and Monitoring Board's recommendation. The LifeSkills intervention was delivered in six 2-hour sessions spanning a 3-week period.Main outcomes and measuresPrimary outcome was change in the number of self-reported condomless anal or vaginal sex acts in the 4 months before the baseline assessment and that reported at the 4-, 8-, and 12-month visits.ResultsOf the 190 study participants, the mean (SD) age was 23.4 (3.4) years (range, 16-29 years); 47 (24.7%) were white, 83 (43.7%) were black or African American, 25 (13.2%) were Hispanic or Latina, and 35 (18.4%) were another race/ethnicity. From baseline to 4 months, the LifeSkills group had a 30.8% greater mean (SE) reduction in condomless sex acts (2.26 [0.40] at baseline vs 1.22 [0.22] at 4 months) compared with the standard of care group (2.69 [0.59] at baseline vs 2.10 [0.47] at 4 months) (risk ratio [RR], 0.69; 95% CI, 0.60-0.80; P < .001). Similarly, the LifeSkills group had a 39.8% greater mean (SE) reduction in condomless sex acts at the 12-month follow-up visit compared with the standard of care group (0.71 [0.13] vs 1.40 [0.32]; RR, 0.60; 95% CI, 0.50-0.72; P < .001).Conclusions and relevanceAmong YTW at sexual risk of HIV acquisition or transmission, the LifeSkills intervention resulted in a 39.8% greater mean reduction in condomless sex acts during the 12-month follow-up in comparison to the standard of care group. This trial is the first to date to demonstrate evidence of efficacy for a behavioral intervention to reduce sexual risk in YTW.Trial registrationClinicalTrials.gov Identifier: NCT01575938.

Project description:Importance:In the United States, the prevalence rates of HIV and sexually transmitted infections (STIs) are higher among individuals in community supervision programs (CSPs) than in the general population. However, to date, no couple-based HIV or STI prevention interventions have been implemented for the large number of men in CSPs. Objective:To determine the effectiveness of a 5-session couple-based prevention intervention, compared with a 1-session counseling, testing, and referral (CTR) program, in reducing HIV and STIs as well as condomless intercourse among men in CSPs and their female sexual partners. Design, Setting, and Participants:A randomized clinical trial was conducted from July 11, 2013 (first recruitment), through May 17, 2016 (last randomization). Participants were drug-involved men mandated to a CSP and their female sexual partners (n = 230 couples or 460 individuals). Participants were recruited from various CSP sites in New York, New York, and randomized into either the PACT (Protect and Connect) intervention condition or the HIV CTR control condition (n = 115 couples or 230 individuals in each arm). Analysis of behavioral outcomes used an intent-to-treat approach. Statistical analyses were conducted from November 1, 2017, through June 1, 2018. Main Outcomes and Measures:Self-reported data on sexual behaviors in the past 90 days were used to assess behavioral outcomes at all time points. Biomarkers were collected at baseline and 12 months, and behavioral outcomes were collected at baseline and 3, 6, and 12 months. Results:A total of 230 couples (460 individuals) were included. The mean (SD) age of participants was 35.0 (12.8) years, and most participants (341 [74.1%]) self-identified as black or African American race/ethnicity. Of the 18 new cases of STIs identified at the 12-month assessment, 10 came from the PACT arm and 8 from the HIV CTR control arm. Compared with the control participants, PACT participants had 33% fewer acts of condomless vaginal and/or anal intercourse with their main partner (incidence rate ratio [IRR], 0.67; 95% CI, 0.45-0.99; P = .04), 70% fewer acts with other partners (IRR, 0.30; 95% CI, 0.12-0.74; P = .009), and 40% fewer acts with all sexual partners (IRR, 0.60; 95% CI, 0.42-0.85; P = .005) over the entire follow-up period. In addition, PACT participants were less likely to report being under the influence of drugs or alcohol the last time they had vaginal and/or anal intercourse with their study partners (odds ratio, 0.55; 95% CI, 0.31-0.96; P = .04) and had 26% fewer sexual partners in the past 90 days (IRR, 0.74; 95% CI, 0.61-0.88; P = .001). At 12 months, HIV and STI incidence did not differ significantly between the 2 arms. Conclusions and Relevance:The PACT intervention appeared to reduce risky sexual behaviors, such as condomless intercourse; this finding suggests that a couple-based HIV and STI prevention intervention program may curb the burgeoning HIV epidemic in CSPs. Clinical Trial Registration:ClinicalTrials.gov identifier: NCT01690494.

Project description:BACKGROUND:Creating inclusive and accessible outdoor environments that provide and encourage opportunities for older adults to engage in physical activity and social interaction is important for healthy ageing. The Senior Exercise Park is outdoor exercise equipment designed specifically for use by older people that provides physical and social benefits for older people in the community, and has the potential to be used widely as a sustainable mode of physical activity. The aim of this study is to implement and evaluate the effects of sustained engagement through the use of a community-based novel outdoor physical activity program (purpose-built exercise park) for older people on physical, mental and social health and physical activity outcomes (the ENJOY project). METHODS:This is a prospective pre-post design study with 12 months follow up. Adults aged ≥60 years will be recruited from the general community from the suburbs close to the Senior Exercise Parks locations in Melbourne. Participants will undergo a 12 week structured supervised physical activity program using the outdoor Senior Exercise Park equipment followed by 6 months unstructured physical activity program. Participants will be assessed at baseline, 3, 9, and 12 months. The following outcomes will be assessed: physical activity, physical function, psychosocial and mental health outcomes, falls risk and falls occurrence, participants' feedback and satisfaction, and health care resource use. DISCUSSION:The ENJOY trial is designed to operate in a community setting with local government engagement to maximise the usage of the exercise park and provide an outdoor space for older people to be physically active. This project will evaluate the effectiveness and sustainability of the outdoor exercise park on a range of health outcomes and its long-term usability in the community. TRIAL REGISTRATION:This trial is prospectively registered with the Australian New Zealand Clinical Trials Registry. Trial registration number ACTRN12618001727235 registered 18th of October 2018.

Project description:IntroductionIn Bangladesh, injury is one of the leading causes of death and morbidity in children. All children under 5 years of age are at high risk for drowning though the risks are highest when children first learn to walk and crawl while they do not understand the danger of water. The Centre for Injury Prevention and Research, Bangladesh (CIPRB) in collaboration with Johns Hopkins International Injury Research Unit (JH-IIRU) has been implementing two drowning prevention interventions, providing playpens and community day care centres (anchal), or both in three rural sub-districts of Bangladesh under Saving of Lives from Drowning (SoLiD) project in Bangladesh. In CIPRB intervention areas, wooden playpens were distributed among the children nine months to three years at household (HH) level.ObjectiveThe aim of this study was to explore and understand the acceptability and perceptions of parents towards playpen and its relevance for drowning and injury related mortality and morbidity prevention.MethodsAnchal mothers ('anchal maa' in Bangla) distributed 30,553 playpens and collected compliance information at the HH level using a structured questionnaire. 1600 trained anchal maas collected data via face to face interviews from May 2014 to November 2015. Playpen compliance visits were conducted periodically on the second and seventh days and every two months after delivering the playpen. Data were entered using standard data entry formats and analyzed using SPSS software version 23.ResultsParents reported that playpen is a safe place and protects children from drowning and other injuries. During compliance data collection, anchal maa founds that 71.8% of all children were using playpen and 93.7% (of 71.8%) children were playing inside the playpen while mothers were busy with their household chores like cooking, washing dishes and clothes, taking care of their poultry and domestic animals etc. 95.7% parents reported playpen is being used for keeping the child safe. On an average, the children were placed two to six times per day in a playpen. 99.1% of the children who reported using a playpen did not get any injuries (falls, cuts and bruises) while using the playpen. Satisfaction level with the playpen intervention among mothers was 90.5%. Some respondents suggested improving the playpen utilization by providing toys, adding wheels for ease of mobility, and increasing the height.ConclusionThe playpens were found to be well accepted and utilized for the children, especially when mothers were busy with their household chores.

Project description:Women who deliver preterm infants are at a much greater risk for repeating a preterm birth (PTB), compared to women without a history of PTB. However, little is known about the prevalence of the risk factors which account for this markedly increased risk. Moreover, little or nothing is known about the feasibility of providing treatments and services to these women, outside of the context of prenatal care, during the inter-conception period, which provides the best opportunity for successful risk-reduction interventions.The Philadelphia Collaborative Preterm Prevention Project (PCPPP), a large randomized control trial designed to identify and reduce six major risk factors for a repeat preterm birth among women immediately following the delivering of a preterm infant. For the women assigned to the PCPPP treatment group, we calculated the prevalence of the six risk factors in question, the percentages of women who agreed to receive high quality risk-appropriate treatments or services, and the of rates of participation among those who were offered and eligible for these treatments or services.Urogenital tract infections were identified in 57% of the women, while 59% were found to have periodontal disease. More than 39% were active smokers, and 17% were assessed with clinical depression. Low literacy, and housing instability were identified in, 22 and 83% of the study sample, respectively. Among women eligible for intervention, the percentages who accepted and at least minimally participated in treatment ranged from a low of 28% for smoking, to a high of 85% for urogenital tract infection. Most PCPPP enrollees (57%) had three or more major risk factors. Participation rates associated with the PCPPP treatments or services varied markedly, and were quite low in some cases, despite considerable efforts to reduce the barriers to receiving care.The efficacy of individual level risk-reduction efforts designed to prevent preterm/repeat preterm in the pre- or inter-conception period may be limited if participation rates associated with interventions to reduce major risk factors for PTB are low. Achieving adequate participation may require identifying, better understanding, and eliminating barriers to access, beyond those associated with cost, transportation, childcare, and service location or hours of operation.ClinicalTrials.gov ( NCT01117922 ).

Dataset Information

Efficacy of a group-based multimedia HIV prevention intervention for drug-involved women under community supervision: project WORTH.

Importance

Objective

Design, setting, participants, and intervention

Main outcomes and measures

Results

Conclusion and relevance

Trial registration

Publications

Efficacy of a group-based multimedia HIV prevention intervention for drug-involved women under community supervision: project WORTH.

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