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Cluster randomized stepped-wedge trial of a multi-level HIV prevention intervention to decrease amphetamine-type stimulants and sexual risk in Cambodian female entertainment and sex workers.

ABSTRACT: BACKGROUND:HIV prevention for female entertainment and sex workers (FESW) may be optimized by addressing individual and structural risks. We examined the impact of a sequentially delivered intervention to decrease sexual risk, amphetamine-type stimulant (ATS) use, and improve economic well-being in Cambodian FESW. METHODS:A cluster randomized stepped-wedge trial was conducted in 10 Cambodian provinces to test multi-level intervention in high risk FESW. After baseline screening in 1198 women, those screening positive for ATS use disorder were allocated to a 12-week conditional cash transfer intervention followed by a 4-week cognitive-behavioural aftercare group (CCT?+?AC). At six months, ATS abstinent participants were offered a microenterprise (ME) opportunity. Co-primary outcomes assessed in 600 FESW at each 6-, 12- and 18-month follow-up assessments, included: 1) number of sexual partners (past three months); and 2) ATS urine toxicology positive (Tox+) results. Secondary outcomes included indicators of economic well-being. RESULTS:Relative to baseline, FESW reported fewer sexual partners at all follow-up assessments with a significant 50% decrease at 12-months (Adjusted Rate Ratio [ARR]?=?0.50; 95%CI: 0.25, 0.95). Women had 60% lower odds of being ATS Tox+ (Adjusted Odds Ratio [AOR]?=?0.40; 95%CI: 0.25, 0.65) at 6-months, and continued but non-significant reductions at 12- and 18-months. Improvements in economic well-being indicators were observed at 12- and 18-months. CONCLUSIONS:Findings support the robust effectiveness of the sequentially delivered CCT?+?AC and ME interventions for boosting HIV prevention for Cambodian FESW. Further research is needed to inform the scale up and improve durability of this comprehensive approach with FESW in Southeast Asia.

SUBMITTER: Page K

PROVIDER: S-EPMC6392432 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Cluster randomized stepped-wedge trial of a multi-level HIV prevention intervention to decrease amphetamine-type stimulants and sexual risk in Cambodian female entertainment and sex workers.

Page Kimberly K Carrico Adam W AW Stein Ellen E Evans Jennifer J Sokunny Muth M Maly Phou P Sophal Chhit C Neak Yuthea Y Ngak Song S McCulloch Charles C Maher Lisa L

Drug and alcohol dependence 20190111

<h4>Background</h4>HIV prevention for female entertainment and sex workers (FESW) may be optimized by addressing individual and structural risks. We examined the impact of a sequentially delivered intervention to decrease sexual risk, amphetamine-type stimulant (ATS) use, and improve economic well-being in Cambodian FESW.<h4>Methods</h4>A cluster randomized stepped-wedge trial was conducted in 10 Cambodian provinces to test multi-level intervention in high risk FESW. After baseline screening in ...[more]

PMID: 30659994

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Project description:BackgroundHIV prevalence remains high in Cambodia among female entertainment and sex workers (FESW), and amphetamine-type stimulant (ATS) use significantly increases risk of infection. A successful continuum of care (CoC) is key to effective clinical care and prevention. This study aimed to describe the HIV CoC in HIV-positive FESW. We examined CoC outcomes among HIV-positive FESW participating in the Cambodia Integrated HIV and Drug Prevention Implementation (CIPI) study, being implemented in ten provinces. CIPI is a trial aimed at reducing ATS use concomitant with the SMARTgirl HIV prevention program.MethodsFrom 2013 to 2016, 1198 FESW ≥ 18 years old who reported multiple sex partners and/or transactional sex were recruited. We identified 88 HIV-positive women at baseline. We described linkage to care as 12-month retention and viral suppression (<1000 copies/mL). Logistic regression analyses were conducted to examine correlates of retention in care at 12 months, and viral suppression.ResultsMedian age of the 88 HIV-positive women was 32 years [interquartile range (IQR) 28, 35]; 50% were working in entertainment venues and 50% as freelance sex workers; 70% reported SMARTgirl membership. In the past 3 months, women reported a median of 15 sex partners, 38% reported unprotected sex, and 55% reported using ATS. Overall, 88% were receiving HIV care, 83% were on antiretroviral therapy, 39% were retained in care at 12 months, and 23% were virally suppressed. SMARTgirl membership was independently associated with fourfold greater odds of 12-month retention in care (AOR = 4.16, 95% CI 1.38, 12.56). Those at high risk for an ATS use disorder had 91% lower odds of 12-month retention in care (AOR = 0.09, 95% CI 0.01, 0.72). Viral suppression was independently associated with SMARTgirl membership, older age, reporting of STI symptoms, worse symptoms of psychological distress, and greater numbers of sex partners.ConclusionsThis is the first study to characterize the HIV CoC in Cambodian FESW. While most women were successfully linked to HIV care, retention and viral suppression were low. Tailored programs like SMARTgirl, targeting the broader population of HIV-positive FESW as well as interventions to reduce ATS use could optimize the clinical and population health benefits of HIV treatment. Trial registration This work reports data collected as part of a trial: NCT01835574. This work does not present trial results.

Project description:In Cambodia, there has been an increase in entertainment work as a result of the breakdown of the traditional brothel-based sex industry, presenting new challenges to addressing the health issues and needs of people working in the entertainment industry. This study aims to identify factors associated with psychological distress among female entertainment workers (FEWs) in Cambodia.A two-stage cluster sampling method was used to randomly select 657 FEWs from entertainment establishments in Phnom Penh and Siem Reap in April and May 2014 for interviews using a structured questionnaire. Psychological distress was measured using the General Health Questionnaire (GHQ-12), and multivariate logistic regression analysis was conducted.Almost half of FEWs (43.2 %) had a higher level of psychological distress (GHQ-12 > 3), while 19.5 % reported having suicidal thoughts, and 7.3 % reported having attempted to commit suicide in the past 3 months. Controlling for confounding factors, women with a higher level of psychological distress were significantly more likely to rate their overall health (AOR = 1.88, 95 % CI 1.20 to 2.94) and quality of life (AOR = 2.39, 95 % CI 1.47 to 3.87) as poor. They were also significantly more likely to have suicidal ideation (AOR = 2.41, 95 % CI 1.45 to 3.76), rate their HIV risk as higher than the general population (AOR = 0.48, 95 % CI 0.31 to 0.74), have been forced to drink at work (AOR = 1.77, 95 % CI 1.19 to 2.62), have had clients requesting not to use a condom (AOR = 3.48, 95 % CI 1.14 to 10.62), be not able to find condoms when they needed it (AOR = 0.64, 95 % CI 0.45 to 0.93), have had a family member who said hurtful things to them during childhood (AOR = 1.84, 95 % CI 1.24 to 2.75), and have had a parent or guardian who had been physically abused (AOR = 1.93, 95 % CI 1.34 to 2.82).FEWs in Cambodia experience high levels of psychological distress, which likely stems from both past negative experiences and current working conditions. For women that are experiencing psychological distress, intervention programs aimed at improving mental health should specifically address substance use, condom availability and negotiation skills, and suicide risk.

Project description:BACKGROUND:In Cambodia, HIV prevalence is concentrated in key populations including among female entertainment workers (FEWs) who may engage in direct or indirect sex work. Reaching FEWs with sexual and reproductive health (SRH) services has been difficult because of their hidden and stigmatized nature. Mobile-phone-based interventions may be an effective way to reach this population and connect them with the existing services. This article describes study design and implementation of a randomized controlled trial (RCT) of a mobile health intervention (the Mobile Link) aiming to improve SRH and related outcomes among FEWs in Cambodia. METHODS:A two-arm RCT will be used to determine the effectiveness of a mobile-phone-based text/voice messaging intervention. The intervention will be developed through a participatory process. Focus group discussions and in-depth interviews have been conducted to inform and tailor behavior change theory-based text and voice messages. During the implementation phase, 600 FEWs will be recruited and randomly assigned into one of the two arms: (1) a control group and (2) a mobile phone message group (either text messages [SMS] or voice messages [VM], a delivery method chosen by participants). Participants in the control group will also receive a weekly monitoring survey, which will provide real-time information to implementing partners to streamline outreach efforts and be able to quickly identify geographic trends. The primary outcome measures will include self-reported HIV and sexually transmitted infections (STI) testing and treatment, condom use, contraceptive use, and gender-based violence (GBV). DISCUSSION:If the Mobile Link trial is successful, participants will report an increase in condom use, linkages to screening and treatment for HIV and STI, and contraception use as well as a reduction in GBV. This trial is unique in a number of ways. First, the option of participation mode (SMS or VM) allows participants to choose the message medium that best links them to services. Second, this is the first RCT of a mobile-phone-based behavior change intervention using SMS/VMs to support linkage to SRH services in Cambodia. Lastly, we are working with a hidden, hard-to-reach, and dynamic population with which existing methods of outreach have not been fully successful. TRIAL REGISTRATION:Clinical trials.gov, NCT03117842 . Registered on 31 March 2017.

Project description:BackgroundCambodia has been well recognized for its success in the fight against the HIV epidemic. However, challenges remain in eliminating HIV infections in key populations, including women working in entertainment establishments, such as massage parlors, karaoke bars, or beer gardens. This study explored the prevalence of HIV and identified factors associated with HIV infection among female entertainment workers (FEWs) in Cambodia.MethodsThis national biological and behavioral survey was conducted in 2016 in Phnom Penh and 17 provinces. We used a two-stage cluster sampling method to recruit FEWs for HIV testing performed on-site and face-to-face interviews using a structured questionnaire. We investigated factors associated with HIV infection using multiple logistic regression.ResultsThis study included 3149 FEWs with a mean age of 26.2 years (SD 5.7). The adjusted prevalence of HIV was 3.2% (95% CI 1.76-5.75). In the multiple logistic regression model, the odds of HIV infection were significantly higher among FEWs in the age group of 31 to 35 (AOR 2.72, 95% CI 1.36-8.25) and 36 or older (AOR 3.62, 95% CI 1.89-10.55); FEWs who were not married but living with a sexual partner (AOR 3.00, 95% CI 1.16-7.79); FEWs who had at least ten years of formal education (AOR 0.32, 95% CI 0.17-0.83); FEWs who reported having abnormal vaginal discharge (AOR 3.51, 95% CI 1.12-9.01), genital ulcers or sores (AOR 2.06, 95% CI 1.09-3.17), and genital warts (AOR 2.89, 95% CI 1.44-6.33) in the past three months; and FEWs who reported using illicit drugs (AOR 3.28, 95% CI 1.20-4.27) than their respective reference group. The odds of HIV infection were significantly lower among FEWs working in karaoke bars (AOR 0.26, 95% CI 0.14-0.50) and beer gardens (AOR 0.17, 95% CI 0.09-0.54) than among freelance FEWs.ConclusionsThe prevalence of HIV among FEWs in Cambodia remains much higher than that in the general population. These findings indicate that differentiated strategies to address HIV and other sexually transmitted infections should be geared towards FEWs working as freelancers or in veiled entertainment venues such as massage parlors and freelance sex workers. Prevention efforts among venue-based FEWs should be sustained.

Project description:BackgroundAmphetamine-type stimulants (ATS) refer to a group of synthetic stimulants including amphetamine, methamphetamine, 3,4-methylenedioxy-methamphetamine (MDMA) and related substances. ATS are highly addictive and prolonged use may result in a series of mental and physical symptoms including anxiety, confusion, insomnia, mood disturbances, cognitive impairments, paranoia, hallucinations and delusion.Currently there is no widely accepted treatment for ATS-use disorder. However, cognitive-behavioural treatment (CBT) is the first-choice treatment. The effectiveness of CBT for other substance-use disorders (e.g. alcohol-, opioid- and cocaine-use disorders) has been well documented and as such this basic treatment approach has been applied to the ATS-use disorder.ObjectivesTo investigate the efficacy of cognitive-behavioural treatment for people with ATS-use disorder for reducing ATS use compared to other types of psychotherapy, pharmacotherapy, 12-step facilitation, no intervention or treatment as usual.Search methodsWe identified randomised controlled trials (RCT) and quasi-RCTs comparing CBT for ATS-use disorders with other types of psychotherapy, pharmacotherapy, 12 step facilitation or no intervention. We searched the Cochrane Drugs and Alcohol Group Specialised Register, Cochrane Central Register of Controlled Trials, MEDLINE via PubMed, Embase and five other databases up to July 2018. In addition, we examined reference lists of eligible studies and other systematic reviews. We contacted experts in the field.Selection criteriaEligibility criteria consisted of RCTs and quasi-RCTs comparing CBT versus other types of interventions with adult ATS users (aged 18 years or older) diagnosed by any explicit diagnostic system. Primary outcomes included abstinence rate and other indicators of drug-using behaviours.Data collection and analysisWe used standard methodological procedures expected by Cochrane.Main resultsOnly two studies met the eligibility criteria. Both studies were at low risk of selection bias and reporting bias. In one study, almost half of participants in the intervention group dropped out and this study was at high risk of attrition bias. The studies compared a single session of brief CBT or a web-based CBT to a waiting-list control (total sample size across studies of 129). Results were mixed across the studies. For the single-session brief CBT study, two out of five measures of drug use produced significant results, percentage of abstinent days in 90 days (odds ratio (OR) 0.22, 95% confidence interval (CI) 0.02 to 2.11) and dependence symptoms (standardised mean difference (SMD) -0.59, 95% CI-1.16 to-0.02). Little confidence could be placed in the results from this study give the small sample size (25 participants per group) and corresponding large CIs around the observed effects. For the web-based CBT, there was no significant difference across different outcomes. Neither study reported adverse effects. The meta-analytic mean across these two trials for drug use was not significant (SMD -0.28, 95% CI-0.69 to 0.14). In summary, overall quality of evidence was low and there was insufficient evidence to conclude that CBT is effective, or ineffective, at treating ATS use.Authors' conclusionsCurrently, there is not enough evidence to establish the efficacy of CBT for ATS-use disorders because of a paucity of high-quality research in this area.

Project description:BackgroundMobile Link is a mobile phone-based intervention to increase access to, and use of, health care services among female entertainment workers in Cambodia who face higher risks for specific diseases and gender-based violence. A multisite randomized controlled trial showed that Mobile Link connected female entertainment workers with outreach workers for information and escorted referrals after 6 months but did not lead to statistically significant improvements in HIV and sexually transmitted infection testing, contraceptive use, and condom use.ObjectiveThis study aims to conduct a 3-part economic evaluation of Mobile Link to understand its costs, value, and affordability.MethodsWe conducted cost, cost-effectiveness, and budget impact analyses of Mobile Link using cost and outcomes data from the Mobile Link trial and other sources. For the cost analysis, we estimated the total, per-person, and incremental costs of Mobile Link compared with usual care. Using probabilistic decision-analytic models, we estimated the 1-year cost-effectiveness of Mobile Link from payer and combined payer and patient perspectives by converting selected primary and secondary outcomes from the trial to disability-adjusted life years (DALYs) averted. Finally, we estimated the financial costs of scaling up Mobile Link's messaging and outreach services to 70% of female entertainment workers in 5 years.ResultsThe incremental costs of Mobile Link were US $199 from a payer perspective and US $195 per person from a combined payer and patient perspective. With an average of 0.018 (95% predicted interval -0.088 to 0.126) DALYs averted, Mobile Link's cost-effectiveness was US $10,955 per DALY from a payer perspective (US $10,755 per DALY averted from a payer and patient perspective). The costs of Mobile Link would have to decrease by 85%, or its effectiveness would have to be 5.56 times higher, for the intervention to meet the upper limit of recommended cost-effectiveness thresholds in Cambodia (US $1671 per DALY averted). The 5-year cost of scaling Mobile Link to 34,790 female entertainment workers was estimated at US $1.64 million or US $46 per person per year.ConclusionsThis study provided a comprehensive economic evaluation of Mobile Link. We found that Mobile Link is not likely to be cost-effective unless its costs decrease or its effectiveness increases. Scaling up Mobile Link to more female entertainment workers is estimated to cost less than the costs of the trial. Given the importance of linking female entertainment workers to essential services, future research should focus on enhancing the effectiveness of Mobile Link or developing new mobile health interventions for this population.Trial registrationClinicalTrials.gov NCT03117842; https://clinicaltrials.gov/study/NCT03117842.

Project description:BackgroundStepped wedge randomised trial designs involve sequential roll-out of an intervention to participants (individuals or clusters) over a number of time periods. By the end of the study, all participants will have received the intervention, although the order in which participants receive the intervention is determined at random. The design is particularly relevant where it is predicted that the intervention will do more good than harm (making a parallel design, in which certain participants do not receive the intervention unethical) and/or where, for logistical, practical or financial reasons, it is impossible to deliver the intervention simultaneously to all participants. Stepped wedge designs offer a number of opportunities for data analysis, particularly for modelling the effect of time on the effectiveness of an intervention. This paper presents a review of 12 studies (or protocols) that use (or plan to use) a stepped wedge design. One aim of the review is to highlight the potential for the stepped wedge design, given its infrequent use to date.MethodsComprehensive literature review of studies or protocols using a stepped wedge design. Data were extracted from the studies in three categories for subsequent consideration: study information (epidemiology, intervention, number of participants), reasons for using a stepped wedge design and methods of data analysis.ResultsThe 12 studies included in this review describe evaluations of a wide range of interventions, across different diseases in different settings. However the stepped wedge design appears to have found a niche for evaluating interventions in developing countries, specifically those concerned with HIV. There were few consistent motivations for employing a stepped wedge design or methods of data analysis across studies. The methodological descriptions of stepped wedge studies, including methods of randomisation, sample size calculations and methods of analysis, are not always complete.ConclusionWhile the stepped wedge design offers a number of opportunities for use in future evaluations, a more consistent approach to reporting and data analysis is required.

Dataset Information

Cluster randomized stepped-wedge trial of a multi-level HIV prevention intervention to decrease amphetamine-type stimulants and sexual risk in Cambodian female entertainment and sex workers.

Publications

Cluster randomized stepped-wedge trial of a multi-level HIV prevention intervention to decrease amphetamine-type stimulants and sexual risk in Cambodian female entertainment and sex workers.

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