Dataset Information

Pay-it-forward gonorrhea and chlamydia testing among men who have sex with men and male STD patients in China: the PIONEER pragmatic, cluster randomized controlled trial protocol.

ABSTRACT:

Background

Gonorrhea and chlamydia are the most common sexually transmitted diseases (STDs) among men who have sex with men (MSM) in China. Previous studies have shown pay-it-forward (PIF) interventions to be associated with a substantial increase in gonorrhea and chlamydia test uptake compared to standard-of-care. We propose a 'pay-it-forward' gonorrhea and chlamydia testing randomized controlled trial (PIONEER). The trial would evaluate the effectiveness of two pay-it-forward strategies in promoting testing uptake compared to the standard of care (in which men pay for their tests out-of-pocket) among MSM and male STD patients in China.

Methods

PIONEER will be a three-armed, pragmatic cluster randomized controlled trial (RCT), conducted across 12 clinics (six MSM-led and six public STD clinics) to compare the effectiveness of three implementation strategies. Each facility will be randomized to a standard pay-it-forward intervention of gonorrhea/ chlamydia testing with minimal encouragement for testing, a community-engaged pay-it-forward arm, or a control arm where men pay for their tests out-of-pockets. The primary outcome will be dual gonorrhea/chlamydia test uptake. Secondary outcomes will include syphilis testing, amount donated in pay-it-forward, number of positive gonorrhea and chlamydia tests, and measures of antimicrobial resistance. A sequential transformative mixed methods design will be used to evaluate the implementation process in type 2 effectiveness-implementation hybrid design. Data sources will include survey on acceptability, and feelings and attitudes towards the interventions among participants; testing and treatment uptake data from clinic records, WeChat records, and qualitative data to gain insights into men's perceptions and attitudes towards the pay-it-forward, mechanisms driving uptake, and donating behaviors. Implementers and organizers will be interviewed about fidelity and adherence to protocol, sustainability of pay-it-forward intervention, and barriers and facilitators of implementing the intervention.

Discussion

PIONEER will substantially increase gonorrhea/chlamydia testing among MSM in China, providing an innovative and new financial mechanism to sustain STD screening among sexual minorities in low- and middle-income countries. This study will answer compelling scientific questions about how best to implement pay-it-forward and the individual and organizational characteristics that moderate it.

Trial registration

The study with identification number NCT05723263 has been registered on clinicaltrials.gov/.

SUBMITTER: Marley G

PROVIDER: S-EPMC10280958 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Pay-it-forward gonorrhea and chlamydia testing among men who have sex with men and male STD patients in China: the PIONEER pragmatic, cluster randomized controlled trial protocol.

Marley Gifty G Tan Rayner Kay Jin RKJ Wu Dan D Wang Tong T Sun Murong M Sheng Qilei Q Holly Margaret Elizabeth ME Hlatshwako Takhona Grace TG Wang Cheng C Tang Weiming W Ramaswamy Rohit R Yang Ligang L Luo Danyang D Sylvia Sean S SS Gray Kurt K Van Duin David D Zheng Heping H Tucker Joseph D JD

BMC public health 20230620 1

<h4>Background</h4>Gonorrhea and chlamydia are the most common sexually transmitted diseases (STDs) among men who have sex with men (MSM) in China. Previous studies have shown pay-it-forward (PIF) interventions to be associated with a substantial increase in gonorrhea and chlamydia test uptake compared to standard-of-care. We propose a 'pay-it-forward' gonorrhea and chlamydia testing randomized controlled trial (PIONEER). The trial would evaluate the effectiveness of two pay-it-forward strategie ...[more]

PMID: 37337181

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Project description:BackgroundChinese men who have sex with men (MSM) rarely receive gonorrhoea and chlamydia testing. The purpose of this pilot study was to evaluate a pay-it-forward strategy to increase uptake of gonorrhoea and chlamydia testing among MSM.MethodsWe performed a quasi-experimental pragmatic study to compare a pay-it-forward model with standard of care at two HIV testing sites for MSM in Guangzhou, China: an STD clinic for MSM and a local MSM community-based organisation. All men who arrived at the STD clinic or the community-based organisation were invited to participate. In the pay-it-forward programme, men were offered free gonorrhoea and chlamydia testing and given the option of donating money toward testing for future participants. In the standard-of-care group, men were offered gonorrhoea and chlamydia testing at the standard patient price of ¥150 (about US$21·50). The pay-it-forward programme was implemented for 3 months, after which both sites switched to standard of care offering dual testing for 3 months. The primary outcome for this study was uptake of dual gonorrhoea and chlamydia testing, which we compared using χ2 test and logistic regression, reported as crude odds ratios (cOR) and adjusted odds ratios (aOR), by adjusting for nationality, marital status, income, and site of testing.FindingsThe pay-it-forward programme took place from Dec 2, 2017, to Feb 3, 2018, and the standard-of-care control took place from March 11, 2018, to May 1, 2018. 408 men were included in this study. 203 men were offered pay-it-forward, and 205 were offered standard of care. Overall, 109 (54%) of 203 men in the pay-it-forward group and 12 (6%) of 205 men in the standard-of-care group received gonorrhoea and chlamydia testing (cOR 18·65, 9·78-35·54; p<0·0001; aOR 19·73, 95% CI 10·02-38·85; p<0·0001). Of all 121 men who tested, this was the first gonorrhoea test for 97 (80%) men and the first chlamydia test for 104 (86%) men. Five (4%) of these 121 men were diagnosed with gonorrhoea and 15 (12%) were diagnosed with chlamydia. 97 (89%) of 109 men who received testing in the pay-it-forward group donated some money toward testing for future participants.InterpretationPay-it-forward might be a sustainable model for expanding integrated HIV testing services among MSM in China.FundingNational Institutes of Health, Southern Medical University Dermatology Hospital, Doris Duke Charitable Foundation.

Project description:BackgroundGonorrhea and chlamydia testing rates are poor among Chinese men who have sex with men (MSM). A quasi-experimental study suggested that a pay-it-forward strategy increased dual gonorrhea/chlamydia testing among MSM. Pay-it-forward offers an individual a gift (e.g., a free test) and then asks the same person if they would like to give a gift to another person. This article reports the protocol of a randomized controlled trial to evaluate dual gonorrhea/chlamydia test uptake and other outcomes among MSM in three arms - a pay-it-forward arm, a pay-what-you-want arm, and a standard of care arm.MethodsThree hundred MSM will be recruited at three HIV testing sites in Guangzhou and Beijing. Testing sites include two hospital-based MSM sexually transmitted diseases clinics and one MSM community-based organization. Eligible participants will be born biologically male, aged 16 years or older, reporting previous anal sex with another man, having never participated in the pay-it-forward program, without previous gonorrhea and chlamydia testing in the past 12 months, and residing in China. Following a cluster randomized design, every cluster of ten participants will be randomly allocated into one of three arms: (1) a pay-it-forward arm in which men are offered free gonorrhea and chlamydia testing and then asked whether they would like to donate ("pay it forward") toward testing for future testers; (2) a pay-what-you-want arm in which men are offered free testing and told to decide how much to pay after receiving the test; (3) a standard of care arm in which men can pay the full price for dual gonorrhoea and chlamydia testing. The primary outcome is dual gonorrhoea/chlamydia testing as verified by administrative records. Secondary outcomes include incremental cost per test, incremental cost per diagnosis, community connectedness, and social cohesion. Primary outcome will be calculated for each arm using intention-to-treat and compared using one-sided 95% confidence intervals with a margin of 20% increase defined as superiority.DiscussionThis study will examine the pay-it-forward strategy in comparison to the standard of care in improving test uptake for gonorrhea and chlamydia. We will leverage the cluster randomized controlled trial to provide scientific evidence on the potential effect of pay-it-forward. Findings from this study will shed light on novel intervention methods for increasing preventive health service utilization and innovate ways to finance it among communities.Trial registrationClinicalTrials.gov, NCT03741725 . Registered on 12 November 2018.

Project description:BackgroundRegular chlamydia and gonorrhea testing are essential for key populations, such as female sex workers (FSWs). However, testing cost, stigma, and lack of access prevent FSWs in low- and middle-income countries from receiving chlamydia and gonorrhea testing. A social innovation to address these problems is "pay it forward," where an individual receives a gift (free testing) and then asks whether they would like to give a gift to another person in the community.ObjectiveThis cluster randomized controlled trial examined the effectiveness and cost of the pay-it-forward strategy in increasing access to chlamydia and gonorrhea testing among FSWs in China.MethodsThis trial integrated a pay-it-forward approach into a community-based HIV outreach service. FSWs (aged 18 years or older) were invited by an outreach team from 4 Chinese cities (clusters) to receive free HIV testing. The 4 clusters were randomized into 2 study arms in a 1:1 ratio: a pay-it-forward arm (offered chlamydia and gonorrhea testing as a gift) and a standard-of-care arm (out-of-pocket cost for testing: US $11). The primary outcome was chlamydia and gonorrhea test uptake, as ascertained by administrative records. We conducted an economic evaluation using a microcosting approach from a health provider perspective, reporting our results in US dollars (at 2021 exchange rates).ResultsOverall, 480 FSWs were recruited from 4 cities (120 per city). Most FSWs were aged ≥30 years (313/480, 65.2%), were married (283/480, 59%), had an annual income <US $9000 (301/480, 62.7%), and had never been tested for chlamydia (401/480, 83.5%) or gonorrhea (397/480, 82.7%). Chlamydia and gonorrhea test uptake in the pay-it-forward and standard-of-care arms were 82% (197/240) and 4% (10/240), respectively, with an adjusted proportion difference of 76.7% (lower bound 95% CI 70.8%). All those who tested positive were referred to and received treatment at local sexually transmitted infection clinics. This finding was consistent when adjusting for marital status, income, inconsistent condom use during commercial sex in the last 3 months, and HIV testing history. Among 197 women who received tests in the pay-it-forward arm, 99 (50.3%) donated money, with a median donation of US $1.54 (IQR 0.77-1.54). The economic cost per person tested was US $568.71 for standard of care and US $43.20 for pay it forward.ConclusionsThe pay-it-forward strategy has the potential to enhance chlamydia and gonorrhea testing for Chinese FSWs and may be useful for scaling up preventive services. Further implementation research is needed to inform the transition of pay-it-forward research into practice.Trial registrationChinese Clinical Trial Registry ChiCTR2000037653; https://www.chictr.org.cn/showprojen.aspx?proj=57233.

Project description:BackgroundWHO recommends that men who have sex with men (MSM) receive gonorrhoea and chlamydia testing, but many evidence-based preventive services are unaffordable. The pay-it-forward strategy offers an individual a gift (eg, a test for sexually transmitted diseases) and then asks whether they would like to give a gift (eg, a future test) to another person. This study examined the effectiveness of a pay-it-forward programme to increase gonorrhoea and chlamydia testing among MSM in China.MethodsWe did a randomised controlled superiority trial at three HIV testing sites run by MSM community-based organisations in Guangzhou and Beijing, China. We included MSM aged 16 years or older who were seeking HIV testing and met indications for gonorrhoea and chlamydia testing. Restricted randomisation was done using computer-generated permuted blocks. 30 groups were randomised into three arms (1:1:1): a pay-it-forward arm in which men were offered free gonorrhoea and chlamydia testing and then asked whether they would like to donate for testing of prospective participants, a pay-what-you-want arm in which men were offered free testing and given the option to pay any desired amount for the test, and a standard-of-care arm in which testing was offered at ¥150 (US$22). There was no masking to arm assignment. The primary outcome was gonorrhoea and chlamydia test uptake ascertained by administrative records. We used generalised estimating equations to estimate intervention effects with one-sided 95% CIs and a prespecified superiority margin of 20%. The trial is registered with ClinicalTrials.gov, NCT03741725.FindingsBetween Dec 8, 2018, and Jan 19, 2019, 301 men were recruited and included in the analysis. 101 were randomly assigned to the pay-it-forward group, 100 to the pay-what-you-want group, and 100 to the standard-of-care group. Test uptake for gonorrhoea and chlamydia was 56% (57 of 101 participants) in the pay-it-forward arm, 46% (46 of 100 participants) in the pay-what-you-want arm, and 18% (18 of 100 participants) in the standard-of-care arm. The estimated difference in test uptake between the pay-it-forward and standard-of-care group was 38·4% (95% CI lower bound 28·4%). Among men in the pay-it-forward arm, 54 of 57 (95%) chose to donate to support testing for others.InterpretationThe pay-it-forward strategy can increase gonorrhoea and chlamydia testing uptake among Chinese MSM and could be a useful tool for scaling up preventive services that carry a mandatory fee.FundingUS National Institute of Health; Special Programme for Research and Training in Tropical Diseases, sponsored by UNICEF, UNDP, World Bank, and WHO; the National Key Research and Development Program of China; Doris Duke Charitable Foundation; and Social Entrepreneurship to Spur Health.

Project description:BackgroundBlack men who have sex with men (BMSM) are disproportionately affected by sexually transmitted infections (STI), including chlamydia and gonorrhea. Transactional sex is an hypothesized risk factor for STI acquisition in BMSM.MethodsWe estimated the association of transactional sex with incident chlamydia/gonococcal infection among BMSM using longitudinal data from a randomized trial in Atlanta (2012-2015). BMSM were eligible for inclusion if they tested human immunodeficiency virus (HIV)-antibody-negative and reported both ≥2 male sex partners and any condomless anal sex in the last year. We defined chlamydia/gonorrhea incidence as the first occurrence of either rectal or urogenital chlamydia or gonococcal infections after a negative result at enrollment. We used Poisson regression to estimate the incidence rate (IR) for chlamydia/gonorrhea over 12 months. Incidence rate ratios (IRR) compared estimates by reported experience of transactional sex. Subgroup analyses assessed potential heterogeneity by age and sexual identity.ResultsThis analysis included 416 BMSM, of whom 191 (46%) were gay-identified, 146 (42%) reported a history of transactional sex, and 57 (14%) had prevalent chlamydia/gonococcal infection at baseline. Over a median of 1 year of follow-up, an additional 55 men tested laboratory-positive for chlamydia/gonorrhea (IR, 17.3 per 100 person-years). Transactional sex was not associated with chlamydia/gonorrhea incidence overall. However, among gay-identified BMSM, transactional sex was associated with incident chlamydia/gonorrhea (IRR, 2.9; 95% confidence interval, 1.2-6.8).ConclusionsEconomic and social vulnerabilities may motivate engagement in high-risk sexual behaviors through commodified sex, potentially increasing the burden of STIs among BMSM. In this investigation, the relationship between transactional sex and chlamydia/gonorrhea was not homogenous across BMSM with diverse sexual identities in Atlanta, suggesting that within select sexual networks, transactional sex may drive STI risks. Delivering accessible and targeted STI screening for marginalized BMSM should be prioritized for STI and HIV prevention.

Dataset Information

Pay-it-forward gonorrhea and chlamydia testing among men who have sex with men and male STD patients in China: the PIONEER pragmatic, cluster randomized controlled trial protocol.

Background

Methods

Discussion

Trial registration

Publications

Pay-it-forward gonorrhea and chlamydia testing among men who have sex with men and male STD patients in China: the PIONEER pragmatic, cluster randomized controlled trial protocol.

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