Dataset Information

A cluster-randomized controlled trial of a combination HIV risk reduction and microfinance intervention for female sex workers who use drugs in Kazakhstan.

ABSTRACT:

Introduction

Female sex workers (FSW) who use drugs are a key population at risk of HIV in Kazakhstan, and face multiple structural barriers to HIV prevention. More research is needed on the role of structural interventions such as microfinance (MF) in reducing HIV risk. This paper describes the results of a cluster-randomized controlled trial to test the efficacy of a combination HIVRR + MF intervention in reducing biologically confirmed STIs and HIV risk behaviours.

Methods

This study took place from May 2015 to October 2018 in two cities in Kazakhstan. We screened 763 participants for eligibility and enrolled 354 FSW who use drugs. Participants were randomized in cohorts to receive either a four-session HIVRR intervention, or that same intervention plus 30 additional sessions of financial literacy training, vocational training and asset-building through a matched-savings programme. Repeated behavioural and biological assessments were conducted at baseline, 3-, 6- and 12-months post-intervention. Biological and behavioural primary outcomes included HIV/STI incidence, sexual risk behaviours and drug use risk behaviours, evaluated over the 12-month period.

Results

Over the 12-month follow-up period, few differences in study outcomes were noted between arms. There was only one newly-detected HIV case, and study arms did not significantly differ on any STI incidence. At post-intervention assessments compared to baseline, both HIVRR and HIVRR + MF participants significantly reduced sexual and drug use risk behaviours, and showed improvements in financial outcomes, condom use attitudes and self-efficacy, social support, and access to medical care. In addition, HIVRR + MF participants showed a 72% greater reduction in the number of unprotected sex acts with paying partners at the six-month assessment (IRR = IRR = 0.28, 95% CI = 0.08, 0.92), and a 10% greater reduction in the proportion of income from sex work at the three-month assessment (b = -0.10, 95% CI = -0.17, -0.02) than HIVRR participants did. HIVRR + MF participants also showed significantly improved performance on financial self-efficacy compared to HIVRR over the 12-month follow-up period.

Conclusions

Compared to a combination HIVRR + MF intervention, a robust HIVRR intervention alone may be sufficient to reduce sexual and drug risk behaviours among FSW who use drugs. There may be structural limitations to the promise of microfinance for HIV risk reduction among this population.

SUBMITTER: El-Bassel N

PROVIDER: S-EPMC8100396 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportanceFemale sex workers (FSWs) who use drugs face increased risk of intimate partner violence (IPV) and nonpartner violence (NPV). The association between violence and drug overdose is unknown.ObjectiveTo examine the association between IPV, NPV, and nonfatal drug overdose among FSWs who use drugs in Kazakhstan.Design, setting, and participantsThis cross-sectional study included 400 adult FSWs in Kazakhstan who reported illicit drug use in the past year, exchanged sex for money or drugs, and reported having unprotected sex in the past 90 days. Baseline data were collected from February 2015 to May 2017 from Project Nova, an HIV prevention study among FSWs who use drugs in Kazakhstan. Data analysis was conducted from April 2019 to March 2020.ExposuresLifetime and recent (past 90 day) experiences of physical, sexual, and psychological IPV and NPV using the Revised Conflict Tactics Scale. Subtypes of violence were identified using exploratory factor analysis.Main outcomes and measuresLifetime and recent incidence of nonfatal overdose; sociodemographic characteristics as well as lifetime and recent sex work and drug use behaviors were also collected.ResultsThe 400 participants had a mean (SD) age of 34.1 (8.4) years. Most experienced food insecurity (358 [89.5%]) and homelessness (232 [58.0%]) in the past 90 days; one-third (130 [32.5%]) reported a history of incarceration. Most (359 [89.7%]) experienced some form of violence; 150 (37.5%) reported a lifetime nonfatal overdose, of whom 27 (18.0%) reported nonfatal overdose in the past 90 days. Lifetime severe physical violence (adjusted odds ratio [aOR], 1.27; 95% CI, 1.02-1.59; P = .03), engagement in sex work for more than 10 years (aOR, 2.54; 95% CI, 1.50-4.28; P < .001), and a history of incarceration (aOR, 4.34; 95% CI, 2.58-7.32; P < .001) were associated with greater odds of nonfatal overdose. Engaging in sex work for more than 10 years (aOR, 3.97; 95% CI, 1.36-11.61; P = .01) and a history of incarceration (aOR, 3.63; 95% CI, 1.39-9.48; P = .008) were associated with greater odds of recent nonfatal overdose.Conclusions and relevanceIn this study, violence against FSWs who use drugs in Kazakhstan was associated with increased odds of nonfatal overdose. Harm reduction programs for women should consider including services to address gender-based violence and the needs of women after incarceration.

Project description:BackgroundFemale sex workers who inject drugs (FSW-IDUs) are at risk of acquiring HIV, sexually transmitted infections (STI) and blood-borne infections through unprotected sex and sharing injection equipment. We conducted a 2×2 factorial randomized controlled trial to evaluate combination interventions to simultaneously reduce sexual and injection risks among FSW-IDUs in Tijuana and Ciudad Juarez, Mexico.Methods/designFSW-IDUs ≥18 years reporting sharing injection equipment and unprotected sex with clients within the last month were randomized to one of four conditions based on an a priori randomization schedule, blinding interviewer/counselors to assignment. Due to the extreme vulnerability of this population, we did not include a control group that would deny some women access to preventive information. All women received similar information regardless of group allocation; the difference was in the way the information was delivered and the extent to which women had an interactive role. Each condition was a single 60-minute session, including either an interactive or didactic version of an injection risk intervention and sexual risk intervention. Women underwent interviewer-administered surveys and testing for HIV, syphilis, gonorrhea, Chlamydia, and Trichomonas at baseline and quarterly for 12 months. Combined HIV/STI incidence will be the primary outcome. Secondary outcomes are proportionate reductions in sharing of injection equipment and unprotected sex with clients.DiscussionOf 1,132 women, 548 (48.4%) were excluded (88.9% were ineligible; 11.1% refused to participate or did not return); 584 eligible women enrolled (284 in Tijuana; 300 in Ciudad Juarez). All 584 participants completed the baseline interview, provided biological samples and were randomized to one of the four groups. During follow-up, 17 participants (2.9%) were lost to follow-up, of whom 10 (58.8%) had died, leaving 567 participants for analysis. This study appears to be the first intervention to attempt to simultaneously reduce injection and sexual risk behaviors among FSW-IDUs. The factorial design will permit analysis to determine whether the combination of the two interactive interventions and/or its respective components are effective in reducing injection and/or sexual risks, which will have direct, tangible policy implications for Mexico and potentially other resource-poor countries.Trial registrationNCT00840658.

Project description:IntroductionPunitive legal environments remain a challenge to HIV prevention efforts in Central Asia, and female sex workers who use drugs are vulnerable to police violence. Little is known about the heterogeneity of police violence against female sex workers who use drugs and factors associated with HIV risk in Central Asia, despite the growing HIV epidemic.MethodsWe recruited a community-based sample of 255 female sex workers who use drugs in Almaty, Kazakhstan between February 2015 and May 2017. We used latent class analysis to differentiate women into distinct classes of police violence victimization, and multinomial logistic regression to identify individual-level health outcomes, HIV risk behaviors, and social and structural factors within the risk environment associated with class membership.ResultsA three-class model emerged: Low Victimization (51%), Discrimination and Extortion (15%), and Poly-Victimization (34%). Relative to Low Victimization, factors associated with Poly-Victimization included being positive for HIV and/or sexually-transmitted infections (STI) (aOR: 1.78 (95% CI: 1.01, 3.14)), prior tuberculosis diagnosis (2.73 (1.15, 6.50)), injection drug use (IDU) (2.00 (1.12, 3.58)), greater number of unsafe IDU behaviors (1.21 (1.08, 1.35)), homelessness (1.92 (1.06, 3.48)), greater drug use (1.22 (1.07, 1.39)) and sex work stigma (1.23 (1.06, 1.43)), greater number of sex work clients (2.40 (1.33, 4.31)), working for a boss/pimp (2.74 (1.16, 6.50)), client violence (2.99 (1.65, 5.42)), economic incentives for condomless sex (2.77 (1.42, 5.41)), accessing needle/syringe exchange programs (3.47 (1.42, 8.50)), recent arrest (2.99 (1.36, 6.55)) and detention (2.93 (1.62, 5.30)), and negative police perceptions (8.28 (4.20, 16.3)). Compared to Low Violence, Discrimination and Extortion was associated with lower odds of experiencing intimate partner violence (aOR= 0.26 (0.12, 0.59)), but no other significant associations with the risk environment upon adjusting for socio-demographic characteristics.ConclusionPolice violence against female sex workers who use drugs is pervasive in Kazakhstan. Patterns of police violence vary, with greater HIV susceptibility associated with a higher probability of experiencing multiple forms of police violence. Police sensitization workshops that integrate policing and harm reduction, and drug policy reforms that decriminalize drug use may help mitigate the HIV epidemic in Kazakhstan.

Project description:Highly Exposed-Seronegatives (HESN) individuals do not contract HIV-1 infection despite long-term exposure; few comprehensive studies examining behavior, mucosal tissue, and peripheral immune parameters in sexually-exposed HESN have been completed. To this end, we assessed rate of condomless vaginal sex, the immune activation status (peripheral blood) and gene expression (ectocervical biopsies) in female cohort of high-risk female sex workers [FSW] (n=50) and non-sex worker women [CG] (n=32) in San Juan, Puerto Rico, USA. Of the 50 FSWs examined only 5 had detectable anti-HIV responses by either HIV gag-specific CD8+ T-Cell responses or mucosal anti-HIV envelope IgG/IgA. FSW had a uniform lower CD38 expression on circulating CD4+ or CD8+ T-Cells (both: p<0.0001:Wilcoxon Rank Sum). Cervical tissue from FSWs had greater levels of CD4+ T-Cell (p=0.040), CD123+ plasmacytoid Dendritic Cells (p=0.013) and CD68+ macrophage infiltrates (p=0.038). Cervical gene expression by RNA microarray indicated that FSW had a gene signature characterized by lower expression of genes associated with leukocyte homing and chemotaxis; partial interferon regulated gene signature; and lower gene expression of genes required for HIV infection such as CD4 and NUP153 indicating a lower mucosal immune activation state and reduced susceptibility to HIV-1 infection within mucosal tissue. Notably, Interferon (IFN)-ε expression was higher in FSW than CG women, as detected by RNA (microarray) and protein (IHC) expression in cervical epithelium. The observed levels of IFNε were associated with the reported frequency of unprotected intercourse. Finally, IFNε was induced by treatment of the ECT1 cell line with seminal fluid, suggesting that semen exposure may contribute to long-term protection. Decreased levels of immune activation and gene expression required for HIV infection along with semen-induced epithelial Interferon ε production within the reproductive tract of FSWs highlight distinct host intrinsic resistance mechanisms that may contribute to long-term HIV seronegative status in spite of high-risk condomless sex.

Project description:BackgroundHIV self-testing (HIVST) may play a role in addressing gaps in HIV testing coverage and as an entry point for HIV prevention services. We conducted a cluster randomized trial of 2 HIVST distribution mechanisms compared to the standard of care among female sex workers (FSWs) in Zambia.Methods and findingsTrained peer educators in Kapiri Mposhi, Chirundu, and Livingstone, Zambia, each recruited 6 FSW participants. Peer educator-FSW groups were randomized to 1 of 3 arms: (1) delivery (direct distribution of an oral HIVST from the peer educator), (2) coupon (a coupon for collection of an oral HIVST from a health clinic/pharmacy), or (3) standard-of-care HIV testing. Participants in the 2 HIVST arms received 2 kits: 1 at baseline and 1 at 10 weeks. The primary outcome was any self-reported HIV testing in the past month at the 1- and 4-month visits, as HIVST can replace other types of HIV testing. Secondary outcomes included linkage to care, HIVST use in the HIVST arms, and adverse events. Participants completed questionnaires at 1 and 4 months following peer educator interventions. In all, 965 participants were enrolled between September 16 and October 12, 2016 (delivery, N = 316; coupon, N = 329; standard of care, N = 320); 20% had never tested for HIV. Overall HIV testing at 1 month was 94.9% in the delivery arm, 84.4% in the coupon arm, and 88.5% in the standard-of-care arm (delivery versus standard of care risk ratio [RR] = 1.07, 95% CI 0.99-1.15, P = 0.10; coupon versus standard of care RR = 0.95, 95% CI 0.86-1.05, P = 0.29; delivery versus coupon RR = 1.13, 95% CI 1.04-1.22, P = 0.005). Four-month rates were 84.1% for the delivery arm, 79.8% for the coupon arm, and 75.1% for the standard-of-care arm (delivery versus standard of care RR = 1.11, 95% CI 0.98-1.27, P = 0.11; coupon versus standard of care RR = 1.06, 95% CI 0.92-1.22, P = 0.42; delivery versus coupon RR = 1.05, 95% CI 0.94-1.18, P = 0.40). At 1 month, the majority of HIV tests were self-tests (88.4%). HIV self-test use was higher in the delivery arm compared to the coupon arm (RR = 1.14, 95% CI 1.05-1.23, P = 0.001) at 1 month, but there was no difference at 4 months. Among participants reporting a positive HIV test at 1 (N = 144) and 4 months (N = 235), linkage to care was non-significantly lower in the 2 HIVST arms compared to the standard-of-care arm. There were 4 instances of intimate partner violence related to study participation, 3 of which were related to HIV self-test use. Limitations include the self-reported nature of study outcomes and overall high uptake of HIV testing.ConclusionsIn this study among FSWs in Zambia, we found that HIVST was acceptable and accessible. However, HIVST may not substantially increase HIV cascade progression in contexts where overall testing and linkage are already high.Trial registrationClinicalTrials.gov NCT02827240.

Project description:ImportanceThe increasing HIV incidence rates and suboptimal rates of testing, engagement, and retention in care for people who inject drugs (PWID) in Kazakhstan underscore the need for effective HIV care continuum interventions for PWID.ObjectiveTo determine the effectiveness of the Bridge HIV care continuum intervention implemented in needle and syringe programs (NSPs) in Kazakhstan.Design, setting, and participantsThis stepped-wedge cluster trial was conducted from February 2017 to May 2020, with implementation beginning sequentially across 3 cities (Almaty, Karaganda-Temirtau, and Shymkent) in August 2017, January 2018, and May 2019. Intervention effect sizes were estimated via population-averaged models, and hypothesis testing relied on a permutation testing approach. The primary unit of analysis was an NSP. Data analysis was performed from October 2020 to April 2022.InterventionsThe intervention addresses the full HIV care continuum: identification, testing, referral to services, and linkage to HIV care. The 3 intervention components were (1) a social network strategy, a peer-driven recruitment approach for HIV testing; (2) HIV counseling, rapid testing, and referral following international and national guidelines and protocols; and (3) enhanced antiretroviral treatment and access to services.Main outcomes and measuresThe primary outcomes were the effectiveness of implementing Bridge's enhanced service integration approach in increasing the number of PWID served at NSPs, increasing the number of PWID who are tested for HIV in NSPs, and improving linking HIV-positive PWID with HIV care. Secondary outcomes included numbers of clients registered for HIV care, initiation of antiretroviral therapy, and viral suppression.ResultsTwenty-four NSPs (8 in each city) served a total of 1225 PWID (369 in Almaty, 618 in Karaganda-Temirtau, and 238 in Shymkent) at the preimplementation study step; 1015 clients (82.9%) were male, and the mean (SD) age was 36.7 (7.1) years. Compared with preimplementation study steps, during Bridge intervention implementation steps, NSPs experienced a significant increase in the number of PWID clients registered (incidence rate ratio, 2.37; 95% CI, 1.48-3.78) and the number of PWID who received rapid HIV tests (incidence rate ratio, 3.98; 95% CI, 2.30-6.90). No significant increase in referral to HIV care was observed. The study also found significant support for secondary outcomes of antiretroviral therapy initiation and the number of clients who achieved viral suppression.Conclusions and relevanceIn this stepped-wedge cluster trial, the findings suggest that implementation of the Bridge intervention was associated with significant improvement in several steps in the continuum of HIV care for PWID in Kazakhstan.Trial registrationClinicalTrials.gov Identifier: NCT02796027.

Project description:BACKGROUND:We evaluated the cost-effectiveness of combined single session brief behavioral intervention, either didactic or interactive (Mujer Mas Segura, MMS) to promote safer-sex and safer-injection practices among female sex workers who inject drugs (FSW-IDUs) in Tijuana (TJ) and Ciudad-Juarez (CJ) Mexico. Data for this analysis was obtained from a factorial RCT in 2008-2010 coinciding with expansion of needle exchange programs (NEP) in TJ, but not in CJ. METHODS:A Markov model was developed to estimate the incremental cost per quality adjusted life year gained (QALY) over a lifetime time frame among a hypothetical cohort of 1,000 FSW-IDUs comparing a less intensive didactic vs. a more intensive interactive format of the MMS, separately for safer sex and safer injection combined behavioral interventions. The costs for antiretroviral therapy was not included in the model. We applied a societal perspective, a discount rate of 3% per year and currency adjusted to US$2014. A multivariate sensitivity analysis was performed. The combined and individual components of the MMS interactive behavioral intervention were compared with the didactic formats by calculating the incremental cost-effectiveness ratios (ICER), defined as incremental unit of cost per additional health benefit (e.g., HIV/STI cases averted, QALYs) compared to the next least costly strategy. Following guidelines from the World Health Organization, a combined strategy was considered highly cost-effective if the incremental cost per QALY gained fell below the gross domestic product per capita (GDP) in Mexico (equivalent to US$10,300). FINDINGS:For CJ, the mixed intervention approach of interactive safer sex/didactic safer injection had an incremental cost-effectiveness ratio (ICER) of US$4,360 ($310-$7,200) per QALY gained compared with a dually didactic strategy. Using the dually interactive strategy had an ICER of US$5,874 ($310-$7,200) compared with the mixed approach. For TJ, the combination of interactive safer sex/didactic safer injection had an ICER of US$5,921 ($104-$9,500) per QALY compared with dually didactic. Strategies using the interactive safe injection intervention were dominated due to lack of efficacy advantage. The multivariate sensitivity analysis showed a 95% certainty that in both CJ and TJ the ICER for the mixed approach (interactive safer sex didactic safer injection intervention) was less than the GDP per capita for Mexico. The dual interactive approach met this threshold consistently in CJ, but not in TJ. INTERPRETATION:In the absence of an expanded NEP in CJ, the combined-interactive formats of the MMS behavioral intervention is highly cost-effective. In contrast, in TJ where NEP expansion suggests that improved access to sterile syringes significantly reduced injection-related risks, the interactive safer-sex combined didactic safer-injection was highly cost-effective compared with the combined didactic versions of the safer-sex and safer-injection formats of the MMS, with no added benefit from the interactive safer-injection component.

Project description:BackgroundCisgender female sex workers (FSWs) experience high rates of HIV and sexually transmitted infections (STIs), including chlamydia and gonorrhea. Community empowerment-based responses to the risk environment of FSWs have been associated with significant reductions in HIV and STI risk and associated risk behaviors; however, evaluations of US-based interventions targeting FSWs are limited.ObjectiveThe objective of this study is to describe the design, implementation, and planned evaluation strategy of an ongoing comprehensive community-level intervention in Baltimore City, Maryland, which aims to improve HIV and STI risk and cumulative incidence among FSWs. The two intervention components are the SPARC (Sex Workers Promoting Action, Risk Reduction, and Community Mobilization) drop-in center and the accompanying comprehensive mobile outreach program. The mission of SPARC is to provide low-barrier harm reduction services to FSWs, with a special focus on women who sell sex and use drugs. Services are provided through a harm reduction framework and include reproductive health and sexual health care; medication-assisted treatment; legal aid; counseling; showers, lockers, and laundry; and the distribution of harm reduction tools, including naloxone and sterile drug use supplies (eg, cookers, cotton, syringes, and pipes).MethodsThe SPARC intervention is being evaluated through the EMERALD (Enabling Mobilization, Empowerment, Risk Reduction, and Lasting Dignity) study, which consists of a prospective 2-group comparative nonrandomized trial (n=385), a cross-sectional survey (n=100), and in-depth interviews assessing SPARC implementation (n=45). Participants enrolled in the nonrandomized trial completed a survey and HIV and STI testing at 4 intervals (baseline and 6, 12, and 18 months). Participants recruited from predefined areas closest to SPARC comprised the intervention group, and participants from all other areas of Baltimore were included in the control group.ResultsWe hypothesize that addressing structural drivers and more immediate medical needs, in combination with peer outreach, will improve the HIV and STI risk environment, leading to community empowerment, and reduce the HIV and STI cumulative incidence and behavioral risks of FSWs. Data collection is ongoing. A baseline description of the cohort is presented.ConclusionsIn the United States, structural interventions aimed at reducing HIV and STIs among FSWs are scarce; to our knowledge, this is the first intervention of its kind in the United States. The results of the EMERALD study can be used to inform the development of future interventions targeting FSWs and other at-risk populations.Trial registrationClinicalTrials.gov NCT04413591; https://clinicaltrials.gov/ct2/show/NCT04413591.International registered report identifier (irrid)DERR1-10.2196/23412.