***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Background : Community empowerment approaches have been found to be effective in responding to HIV among female sex workers ( FSWs ) in South Asia and Latin America . To date , limited rigorous evaluations of these approaches have been conducted in sub-Saharan Africa . Methods : A phase II community r and omized controlled trial is being conducted in Iringa , Tanzania , to evaluate the effectiveness of a community empowerment – based combination HIV prevention model ( Project Shikamana ) among a stratified sample of HIV-infected and HIV-uninfected FSWs . Cohort members were recruited from entertainment venues across 2 communities in the region using time-location sampling . All study participants gave consent , and were surveyed and screened for HIV at baseline . Primary biological study outcomes are viral suppression among the HIV-infected and remaining free of HIV among HIV-uninfected women . Results : A cohort of 496 FSWs was established and is currently under follow-up . Baseline HIV prevalence was 40.9 % ( 203/496 ) . Among HIV-infected FSWs , 30.5 % ( 62/203 ) were previously aware of their HIV status ; among those who were aware , 69.4 % were on antiretroviral therapy ( 43/62 ) ; and for those on antiretroviral therapy , 69.8 % ( 30/43 ) were virally suppressed . Factors associated with both HIV infection and viral suppression at baseline included community , age , number of clients , and substance use . Amount of money charged per client and having tested for sexually transmitted infection in the past 6 months were protective for HIV infection . Social cohesion among FSWs was protective for viral suppression . Conclusions : Significant gaps exist in HIV service coverage and progress toward reaching the 90 - 90 - 90 goals among FSWs in Iringa , Tanzania .  Community empowerment approaches hold promise given the high HIV prevalence , limited services and stigma , discrimination , and violence Background Nearly three decades into the epidemic , sub-Saharan Africa ( SSA ) remains the region most heavily affected by human immunodeficiency virus ( HIV ) , with nearly 70 % of the 34 million people living with HIV globally residing in the region . In SSA , female and male youth ( 15 to 24 years ) are at a disproportionately high risk of HIV infection compared to adults . As such , there is a need to target HIV prevention strategies to youth and to tailor them to a gender-specific context . This protocol describes the process for the multi-staged approach in the design of the MP3 Youth pilot study , a  gender-specific , combination , HIV prevention intervention for youth in Kenya . Objective The objective of this multi- method protocol is to outline a rigorous and replicable methodology for a gender-specific combination HIV prevention pilot study for youth in high-burden setting s , illustrating the triangulated methods undertaken to ensure that age , sex , and context are integral in the design of the intervention . Methods The mixed- methods , cross-sectional , longitudinal cohort pilot study protocol was developed by first conducting a systematic review of the literature , which shaped focus group discussion s around prevention package and delivery options , and that also informed age- and sex- stratified mathematical modeling . The review , qualitative data , and mathematical modeling created a triangulated evidence base of interventions to be included in the pilot study protocol . To design the pilot study protocol , we convened an expert panel to select HIV prevention interventions effective for youth in SSA , which will be offered in a mobile health setting . The goal of the pilot study implementation and evaluation is to apply lessons learned to more effective HIV prevention evidence and programming . Results The combination HIV prevention package in this protocol includes ( 1 ) offering HIV testing and counseling for all youth ; ( 2 ) voluntary medical circumcision and condoms for males ; ( 3 ) pre-exposure prophylaxis ( PrEP ) , conditional cash transfer ( CCT ) , and contraceptives for females ; and ( 4 ) referrals for HIV care among those identified as HIV-positive . The combination package platform selected is mobile health teams in an integrated services delivery model . A cross-sectional analysis will be conducted to determine the uptake of the interventions . To determine long-term impact , the protocol outlines enrolling selected participants in mutually exclusive longitudinal cohorts ( HIV-positive , PrEP , CCT , and HIV-negative ) followed by using mobile phone text messages ( short message service , SMS ) and in-person surveys to prospect ively assess prevention method uptake , adherence , and risk compensation behaviors . Cross-sectional and sub-cohort analyses will be conducted to determine intervention packages uptake . Conclusions The literature review , focus groups , and modeling indicate that offering age- and gender- specific combination HIV prevention interventions that include biomedical , behavioral , and structural interventions can have an impact on HIV risk reduction . Implementing this protocol will show the feasibility of delivering these services at scale . The MP3 Youth study is one of the few combination HIV prevention intervention protocol s incorporating youth- and gender-specific interventions in one delivery setting . Lessons learned from the design of the protocol can be incorporated into the national guidance for combination HIV prevention for youth in Kenya and other high-burden SSA setting s. Trial Registration Clinical Trials.gov NCT01571128 ; http:// clinical trials.gov/ct2/show/NCT01571128?term=MP3+youth&rank=1 ( Archived by WebCite at http://www.webcitation.org/6nmioPd54 Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Introduction Injecting drug use is a primary driver of HIV epidemics in many countries . People who inject drugs ( PWID ) and are HIV infected are often doubly stigmatized and many encounter difficulties reducing risk behaviors . Prevention interventions for HIV-infected PWID that provide enhanced support at the individual , family , and community level to facilitate risk-reduction are needed . Methods 455 HIV-infected PWID and 355 of their HIV negative injecting network members living in 32 sub-districts in Thai Nguyen Province were enrolled . We conducted a two-stage r and omization : First , sub-districts were r and omized to either a community video screening and house-to-house visits or st and ard of care educational pamphlets . Second , within each sub-district , participants were r and omized to receive either enhanced individual level post-test counseling and group support sessions or st and ard of care HIV testing and counseling . This result ed in four arms : 1 ) st and ard of care ; 2 ) community level intervention ; 3 ) individual level intervention ; and 4 ) community plus individual intervention . Follow-up was conducted at 6 , 12 , 18 , and 24 months . Primary outcomes were self-reported HIV injecting and sexual risk behaviors . Secondary outcomes included HIV incidence among HIV negative network members . Results Fewer participants reported sharing injecting equipment and unprotected sex from baseline to 24 months in all arms ( 77 % to 4 % and 24 % to 5 % respectively ) . There were no significant differences at the 24-month visit among the 4 arms ( Wald = 3.40 ( 3 df ) ; p = 0.33 ; Wald = 6.73 ( 3 df ) ; p = 0.08 ) . There were a total of 4 HIV seroconversions over 24 months with no significant difference between intervention and control arms . Discussion Underst and ing the mechanisms through which all arms , particularly the control arm , demonstrated both low risk behaviors and low HIV incidence has important implication s for policy and prevention programming . Trial Registration Clinical Trials.gov Background Female sex workers ( FSWs ) are at increased risk of HIV and STIs compared to women in the general population , and frequently experience violence in their working and domestic lives from a variety of perpetrators , which can enhance this risk . While progress has been made in addressing violence by police and clients , little work has been done to underst and and prevent violence by intimate partners ( IPs ) among FSW population s. Methods Samvedana Plus is a multi-level intervention programme that works with FSWs , their IPs , the sex worker community , and the general population , and aims to reduce violence and increase consistent condom use within these ‘ intimate ’ relationships . The programme involves shifting norms around the acceptability of beating as a form of discipline , challenging gender roles that give men authority over women , and working with men and women to encourage new relationship models based on gender equity and respect . The programme will aim to cover 800 FSWs and their IPs living in 47 villages in Bagalkot district , northern Karnataka . The study is design ed to assess two primary outcomes : the proportion of FSWs who report : ( i ) physical or sexual partner violence ; and ( ii ) consistent condom use in their intimate relationship , within the past 6 months . The evaluation will employ a cluster-r and omised controlled trial design , with 50 % of the village clusters ( n = 24 ) r and omly selected to receive the intervention for the first 24 months and the remaining 50 % ( n = 23 ) receiving the intervention thereafter . Statisticians will be blinded to treatment arm allocation . The evaluation will use an adjusted , cluster-level intention to treat analysis , comparing outcomes in intervention and control villages at midline ( 12 months ) and endline ( 24 months ) . The evaluation design will involve quantitative and qualitative assessment s with ( i ) all FSWs who report an IP ( ii ) IPs ; and process/ implementation monitoring . Baseline data collection was completed in April 2015 , and endline data collection is anticipated in May 2017 . Conclusions This is an innovative intervention programme that aims to address violence by IPs as part of HIV prevention programming with FSWs . Reducing violence is expected to reduce vulnerability to HIV acquisition , and help women to work and live without fear of violence . Trial registration Clinical Trials NCT02807259 Jun 24 2016 ( retrospectively registered ) Non-r and omised studies of the effects of interventions are critical to many areas of healthcare evaluation , but their results may be biased . It is therefore important to underst and and appraise their strengths and weaknesses . We developed ROBINS-I ( “ Risk Of Bias In Non-r and omised Studies - of Interventions ” ) , a new tool for evaluating risk of bias in estimates of the comparative effectiveness ( harm or benefit ) of interventions from studies that did not use r and omisation  to allocate units ( individuals or clusters of individuals ) to comparison groups . The tool will be particularly useful to those undertaking systematic review s that include non-r and omised studies BACKGROUND Despite the high-profile support for combination prevention programmes ( CPPs ) since 2008 , there is little rigorous evidence on their impact and cost-effectiveness . In 2010 , Mexico received funds from the Global Fund to implement a series of behavioural , biomedical , and structural interventions over 3 years targeted to men who have sex with men . The aims of the study were to estimate the impact of the programme across a range of outcomes and cost-effectiveness . METHODS A quasi-experiment was design ed before the implementation of the CPP , in which 24 cities were r and omly selected for impact evaluation and 12 pairs of cities were matched . In practice , though , implementation of the programme was staggered over 1 year . Therefore , we used two different approaches to estimate impact : a difference-in-difference estimation comparing both groups and a dose-response approach using time exposure to the programme at the city level . FINDINGS Results from the difference-in-difference estimation showed modest impact on condom use . However , the dose – response findings revealed a 7.5 % increase in HIV testing per additional year exposed to the programme , relative to baseline coverage ; an increase in awareness of HIV status among HIV-positive individuals of 6.3 % ; a 6.7 % increase in HIV-positive individuals on treatment ; and a 7 % reduction in the perception of stigma/discrimination from healthcare personnel . The cost per person not exposed to an untreated HIV-positive individual was gauged to be US$ 400 . CONCLUSIONS The study provides evidence of the effectiveness and cost of a CPP along the HIV treatment cascade : access to HIV tests , awareness of HIV status , and antiretroviral therapy initiation Introduction : The use of combination HIV prevention interventions ( CHPI ) now represent the st and ard of care to minimize HIV acquisition risks among men who have sex with men ( MSM ) . There has been limited evaluation of these approaches in generalized HIV epidemics and /or where MSM are stigmatized . A peer-based CHPI program to target individual , social , and structural risks for HIV was developed for MSM in Blantyre , Malawi . Methods : To test the feasibility of CHPI , adult MSM were followed prospect ively from January 2012 to May 2013 . Participants ( N = 103 ) completed sociobehavioral surveys and HIV testing at each of the 3 follow-up study visits . Results : Approximately 90 % of participants attended each study visit and 93.2 % ( n = 96 ) completed the final visit . Participants met with peer educators a median of 3 times ( range : 1–10 ) in the follow-up visits 2 and 3 . Condom use at last sex improved from baseline through follow-up visit 3 with main ( baseline : 62.5 % , follow-up 3 : 77.0 % ; P = 0.02 ) and casual male partners ( baseline : 70.7 % , follow-up 3 : 86.3 % ; P = 0.01 ) . Disclosure of sexual behaviors/orientation to family increased from 25 % 
    Output:
    
Findings indicate that combination HIV prevention programmes for marginalised population s have delivered a variety of theory-based behavioural and structural interventions that support improvements in empowerment , inclusion and agency .