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Digital network-based methods may enhance peer distribution of HIV self-testing (HIVST) kits, but interventions that can optimize this approach are needed. We aimed to assess whether monetary incentives and peer referral could improve a secondary distribution program for HIVST among men who have sex with men (MSM) in China. Between October 21, 2019 and September 14, 2020, a 3-arm randomized controlled, single-blinded trial was conducted online among 309 individuals (defined as index participants) who were assigned male at birth, aged 18 years or older, ever had male-to-male sex, willing to order HIVST kits online, and consented to take surveys online. We randomly assigned index participants into one of the 3 arms: (1) standard secondary distribution (control) group (n = 102); (2) secondary distribution with monetary incentives (SD-M) group (n = 103); and (3) secondary distribution with monetary incentives plus peer referral (SD-M-PR) group (n = 104). Index participants in 3 groups were encouraged to order HIVST kits online and distribute to members within their social networks. Members who received kits directly from index participants or through peer referral links from index MSM were defined as alters. Index participants in the 2 intervention groups could receive a fixed incentive ($3 USD) online for the verified test result uploaded to the digital platform by each unique alter. Index participants in the SD-M-PR group could additionally have a personalized peer referral link for alters to order kits online. Both index participants and alters needed to pay a refundable deposit ($15 USD) for ordering a kit. All index participants were assigned an online 3-month follow-up survey after ordering kits. The primary outcomes were the mean number of alters motivated by index participants in each arm and the mean number of newly tested alters motivated by index participants in each arm. These were assessed using zero-inflated negative binomial regression to determine the group differences in the mean number of alters and the mean number of newly tested alters motivated by index participants. Analyses were performed on an intention-to-treat basis. We also conducted an economic evaluation using microcosting from a health provider perspective with a 3-month time horizon. The mean number of unique tested alters motivated by index participants was 0.57 ± 0.96 (mean ± standard deviation [SD]) in the control group, compared with 0.98 ± 1.38 in the SD-M group (mean difference [MD] = 0.41),and 1.78 ± 2.05 in the SD-M-PR group (MD = 1.21). The mean number of newly tested alters motivated by index participants was 0.16 ± 0.39 (mean ± SD) in the control group, compared with 0.41 ± 0.73 in the SD-M group (MD = 0.25) and 0.57 ± 0.91 in the SD-M-PR group (MD = 0.41), respectively. Results indicated that index participants in intervention arms were more likely to motivate unique tested alters (control versus SD-M: incidence rate ratio [IRR = 2.98, 95% CI = 1.82 to 4.89, p-value < 0.001; control versus SD-M-PR: IRR = 3.26, 95% CI = 2.29 to 4.63, p-value < 0.001) and newly tested alters (control versus SD-M: IRR = 4.22, 95% CI = 1.93 to 9.23, p-value < 0.001; control versus SD-M-PR: IRR = 3.49, 95% CI = 1.92 to 6.37, p-value < 0.001) to conduct HIVST. The proportion of newly tested testers among alters was 28% in the control group, 42% in the SD-M group, and 32% in the SD-M-PR group. A total of 18 testers (3 index participants and 15 alters) tested as HIV positive, and the HIV reactive rates for alters were similar between the 3 groups. The total costs were $19,485.97 for 794 testers, including 450 index participants and 344 alter testers. Overall, the average cost per tester was $24.54, and the average cost per alter tester was $56.65. Monetary incentives alone (SD-M group) were more cost-effective than monetary incentives with peer referral (SD-M-PR group) on average in terms of alters tested and newly tested alters, despite SD-M-PR having larger effects. Compared to the control group, the cost for one more alter tester in the SD-M group was $14.90 and $16.61 in the SD-M-PR group. For newly tested alters, the cost of one more alter in the SD-M group was $24.65 and $49.07 in the SD-M-PR group. No study-related adverse events were reported during the study. Limitations include the digital network approach might neglect individuals who lack internet access. Monetary incentives alone and the combined intervention of monetary incentives and peer referral can promote the secondary distribution of HIVST among MSM. Monetary incentives can also expand HIV testing by encouraging first-time testing through secondary distribution by MSM. This social network-based digital approach can be expanded to other public health research, especially in the era of the Coronavirus Disease 2019 (COVID-19). Chinese Clinical Trial Registry (ChiCTR) ChiCTR1900025433.

Increasing HIV testing and treatment coverage among people living with HIV (PLHIV) is essential for achieving global HIV epidemic control. However, compared to women, cis-gender heterosexual men living with HIV are significantly less likely to know their HIV status, initiate anti-retroviral therapy (ART) and achieve viral suppression. This is particularly true in South Africa, where men are also at increased risk of mortality resulting from AIDS-related illnesses. While there is growing knowledge of Treatment as Prevention or the concept Undetectable = Untransmittable (U = U) among PLHIV in Western and high-income countries, the reach and penetration of the U = U message in sub-Saharan Africa remains limited, and few studies have evaluated the impact of accessible and relatable U = U messages on ART initiation and adherence. To address these gaps, rigorous evaluations of interventions that incorporate U = U messages are needed, especially among men in high prevalence settings. Building on our U = U messages that we previously developed for men using behavioral economics insights and a human-centered design, we will conduct two sequential hybrid type 1 effectiveness-implementation trials to evaluate the impact of U = U messages on men's uptake of community-based HIV testing and ART initiation (Trial 1), and retention in care and achievement of viral suppression (Trial 2). For trial 1, a cluster randomized trial will be implemented with HIV testing service site-days (each day at one testing site) randomized to U = U or standard-of-care (SoC) messages inviting men to test for HIV. For trial 2, an individual-level randomized control trial will be implemented, with men initiating ART at six government clinics randomized to receive U = U counselling or SoC treatment adherence messaging. We will incorporate a multi-method evaluation to inform future implementation of U = U messaging interventions. The study will be conducted in the Buffalo City Metro Health District of the Eastern Cape Province and in the Cape Town Metro Health District in the Western Cape Province in South Africa. These trials are the first to rigorously evaluate the impact of U = U messaging on HIV testing uptake, ART initiation and achievement of viral suppression among African men. If effective, these messaging interventions can shape global HIV testing, treatment and adherence counselling guidelines and practices.

To date, no randomized controlled trials have specifically addressed behavior changes after HIV self-testing (HIVST) among transgender women. This study aims to evaluate the effects of HIVST on changes in HIV testing behavior, frequency of condomless sex, and partner numbers among transgender women in China. Participants were recruited from 2 Chinese cities using both online and offline methods. Transgender women were randomly assigned to receive an HIVST intervention. Data from the previous 3 months were collected at baseline, 3 months, and 6 months. The primary outcome was the mean change in the number of HIV tests among transgender women during the 6-month follow-up. An intention-to-treat analysis was conducted. The statistical analysis used analysis of covariance and linear mixed-effects models. From February to June 2021, and 255 transgender women were recruited, of which only 36.5% (93/255) had a steady job, and 27.1% (69/255) earned less than US $414.9 of income per month. They were randomly assigned to the intervention (n=127) and control (n=128) groups. At 6 months, the mean number of HIV tests was 2.14 (95% CI 1.80-2.48) in the intervention group and 1.19 (95% CI 0.99-1.40) in the control group (P<.001), with increases of 0.84 (95% CI 0.54-1.14) and 0.11 (95% CI -0.19-0.41) over 6 months, respectively. The net increase was 0.73 (95% CI 0.31-1.15; P<.001), with a similar adjusted result. No significant differences in the frequency of condomless sex or partner numbers were observed between the 2 groups. HIVST is an effective strategy for enhancing regular HIV testing behavior among transgender women in China. This strategy should be combined with measures to address the financial vulnerability of the transgender women community to reduce subsequent risk behaviors, including condomless sex. Chinese Clinical Trial Registry ChiCTR2000039766; https://www.chictr.org.cn/showproj.html?proj=61402.

With changing drug supplies and associated drug consumption behaviors, HIV transmission has increased among people who inject drugs in the United States. HIV testing and referrals to effective prevention and treatment services are critical for individual and population health, yet multilevel barriers limit access to HIV testing for this population, even within syringe services programs (SSPs). In this organizational-level interrupted time series randomized controlled trial, we will assess the effectiveness and cost-effectiveness of an implementation strategy, the Systems Analysis and Improvement Approach (SAIA), in optimizing HIV testing and referrals to appropriate clinical services among U.S. SSPs. From 01/12/2023 to 01/07/2025, we will recruit a diverse sample of 32 SSPs nationally that directly provide HIV testing to participants. SSPs will be randomized to the active implementation arm (i.e., SAIA-SSP-HIV) or an implementation-as-usual arm (n = 16 organizations per arm). SAIA-SSP-HIV is a flexible, data-driven implementation strategy designed to help optimize SSPs’ delivery of HIV testing and referrals to appropriate clinical services for HIV prevention (e.g., pre-exposure prophylaxis) and treatment. In the active implementation arm, trained SAIA specialists will guide SSPs through three cyclical steps over 12 months: (1) process mapping to identify organization-specific needs, (2) cascade analysis and prioritization of areas for improvement, and (3) testing solutions through continuous quality improvement. In both arms, we will collect outcome data over 21 months (3-month lead-in period, 12-month implementation period, 6-month sustainment period). We will assess the initial and sustained effectiveness of SAIA and calculate its cost and cost-effectiveness. This trial presents a novel opportunity to test the effectiveness of an organization-level implementation strategy for optimizing the delivery of HIV screening and referrals in community settings that are frequented by an at-risk population. If successful, SAIA-SSP-HIV could be adapted for other infectious or chronic disease care cascades within SSPs. Trial registration: ClinicalTrials.gov: NCT06025435 .

The HIV epidemic is rapidly growing among men who have sex with men (MSM) in China, yet HIV testing remains suboptimal. We aimed to determine the impact of HIV self-testing (HIVST) interventions on frequency of HIV testing among Chinese MSM and their sexual partners. This randomized controlled trial was conducted in 4 cities in Hunan Province, China. Sexually active and HIV-negative MSM were recruited from communities and randomly assigned (1:1) to intervention or control arms. Participants in the control arm had access to site-based HIV testing (SBHT); those in the intervention arm were provided with 2 free finger-prick-based HIVST kits at enrollment and could receive 2 to 4 kits delivered through express mail every 3 months for 1 year in addition to SBHT. They were encouraged to distribute HIVST kits to their sexual partners. The primary outcome was the number of HIV tests taken by MSM participants, and the secondary outcome was the number of HIV tests taken by their sexual partners during 12 months of follow-up. The effect size for the primary and secondary outcomes was evaluated as the standardized mean difference (SMD) in testing frequency between intervention and control arms. Between April 14, 2018, and June 30, 2018, 230 MSM were recruited. Mean age was 29 years; 77% attended college; 75% were single. The analysis population who completed at least one follow-up questionnaire included 110 (93%, 110/118) in the intervention and 106 (95%, 106/112) in the control arm. The average frequency of HIV tests per participant in the intervention arm (3.75) was higher than that in the control arm (1.80; SMD 1.26; 95% CI 0.97-1.55; P < 0.001). This difference was mainly due to the difference in HIVST between the 2 arms (intervention 2.18 versus control 0.41; SMD 1.30; 95% CI 1.01-1.59; P < 0.001), whereas the average frequency of SBHT was comparable (1.57 versus 1.40, SMD 0.14; 95% CI -0.13 to 0.40; P = 0.519). The average frequency of HIV tests among sexual partners of each participant was higher in intervention than control arm (2.65 versus 1.31; SMD 0.64; 95% CI 0.36-0.92; P < 0.001), and this difference was also due to the difference in HIVST between the 2 arms (intervention 1.41 versus control 0.36; SMD 0.75; 95% CI 0.47-1.04; P < 0.001) but not SBHT (1.24 versus 0.96; SMD 0.23; 95% CI -0.05 to 0.50; P = 0.055). Zero-inflated Poisson regression analyses showed that the likelihood of taking HIV testing among intervention participants were 2.1 times greater than that of control participants (adjusted rate ratio [RR] 2.10; 95% CI 1.75-2.53, P < 0.001), and their sexual partners were 1.55 times more likely to take HIV tests in the intervention arm compared with the control arm (1.55, 1.23-1.95, P < 0.001). During the study period, 3 participants in the intervention arm and none in the control arm tested HIV positive, and 8 sexual partners of intervention arm participants also tested positive. No other adverse events were reported. Limitations in this study included the data on number of SBHT were solely based on self-report by the participants, but self-reported number of HIVST in the intervention arm was validated; the number of partner HIV testing was indirectly reported by participants because of difficulties in accessing each of their partners. In this study, we found that providing free HIVST kits significantly increased testing frequency among Chinese MSM and effectively enlarged HIV testing coverage by enhancing partner HIV testing through distribution of kits within their sexual networks. Chinese Clinical Trial Registry ChiCTR1800015584.

Background In Africa, dispensing oral HIV pre-exposure prophylaxis (PrEP) within already strained public health facilities has led to prolonged waiting periods and suboptimal experiences for clients. We sought to explore the acceptability of dispensing PrEP semiannually with interim HIV self-testing (HIVST) versus quarterly PrEP dispensing with clinic-based HIV testing to optimize clinic-delivered PrEP services. Methods We conducted a qualitative study within a non-inferiority individual-level randomized controlled trial testing the effect of six-monthly PrEP dispensing with HIVST compared to the standard-of-care three-monthly PrEP dispensing on PrEP clinical outcomes in Kenya (ClinicalTrials.gov: NCT03593629). Eligible participants were ≥ 18 years, refilling PrEP for the first time, and either in an HIV serodifferent relationship (men and women) or singly enrolled (women only). A subset of participants in the intervention group completed serial in-depth interviews (IDIs) at enrollment, six months, and 12 months. We utilized stratified purposive sampling to ensure representation across participant groups. We analyzed our qualitative data thematically using a combination of inductive and deductive approaches, the latter guided by the Theoretical Framework of Acceptability (TFA). Results Between May 2018 and June 2021, we conducted 120 serial IDIs with 55 participants; 64% (35/55) were in a serodifferent relationship, 64% (35/55) were women, and the median age was 32 years (IQR 27–40). Overall, participants found this novel PrEP delivery model highly acceptable; it was well-liked, private (TFA construct: affective attitude), and less burdensome (TFA construct: burden) compared to standard PrEP delivery. Additionally, participants were confident in their ability to participate in the intervention (TFA construct: self-efficacy). Some participants, however, highlighted model disadvantages, including fewer opportunities for in-person counseling and potentially less accurate HIV testing (TFA construct: opportunity costs). Ultimately, most participants reported that the intervention allowed them to achieve their HIV prevention goals (TFA construct: perceived effectiveness) and that their confidence in at-home HIVST and PrEP continuation increased following each semiannual clinic visit. Conclusions Semiannual PrEP clinic visits supported with six-monthly drug dispensing and interim HIVST was acceptable among PrEP users who experienced the intervention in Kenya. More comprehensive pre-intervention counseling and training on HIVST may help alleviate the client concerns presented, which were often resolved over time with intervention experience.

Testing for HIV continues to play a key role in prevention, especially among at-risk populations such as gay, bisexual, and other men who have sex with men (MSM). Incorporating HIV self-testing (HIVST) into testing programs encourages more frequent screening and likely facilitates earlier diagnosis, but little is known about how testing behavior changes after self-testing programs end. In this study, a subset of MSM in the eTest trial who were randomized to receive regular HIVST or clinic testing every three months for 12 months were followed for an additional 12 months. We compared testing rates during the intervention period to this 12-month post-intervention period. Results of a Poisson mixed model showed a significant condition by time interaction (IRR=0.91, SE=0.04, p=.019, %95CI=0.84-0.98). The average marginal predicted probability of testing in a given follow-up among controls was 30.4% during the intervention period and 28.2% post-intervention, versus 70.0% among HIVST condition participants during the intervention period but 23.6% by the end of the post-intervention period. Although regular mail delivery of HIVST increased HIV testing considerably while tests are actively being delivered, testing rates declined to a level similar to those who had not received HIVST after regular delivery stops. These results suggest that regularly delivering HIVST does not encourage longer-term regular testing habits in MSM who typically test infrequently.

Men with have sex with men (MSM) in Africa face high levels of stigma due to elevated HIV exposure (actual or perceived), same-sex practices, and gender non-conformity. These stigmas are documented barriers to HIV prevention and treatment. Most stigma-reduction interventions have focused on single-level targets (e.g., health care facility level [HCF]) and addressed one type of stigma (e.g., HIV), without engaging the multiple intersecting stigmas that MSM encounter. Determining the feasibility and acceptability of multi-level intervention of reducing intersectional stigma and estimating its efficacy on increasing HIV testing are needed. We proposed a mixed method study among MSM in Ghana. First, we will develop the intervention protocol using the Convergence Framework, which combines three interventions that were previously implemented separately in Ghana for reducing stigma at the HCF-level, increasing HIV testing at the peer group-level, and increasing peer social support at the individual-level. Then, we will conduct a cluster randomized controlled trial with four pairs of HCFs matched on staff size. HCFs within each pair are randomized to the HCF-level stigma-reduction intervention or control arm. MSM (n = 216) will be randomized to receive the group-level and individual-level interventions or standard of care control arm. MSM will be assigned to receive HIV testing at one of the HCFs that match their study assignment (intervention or control facility). The frequency of HIV testing between MSM in the study arms at 3 and 6 months will be compared, and the predictors of HIV testing uptake at the HCF, peer group and individual-levels will be assessed using multi-level regression models. These findings from this study will provide important evidence to inform a hybrid implementation-effectiveness trial of a public health intervention strategy for increasing HIV case detection among key populations in sub-Saharan African communities. Accurate information on HIV prevalence can facilitate epidemic control through more precise deployment of public health measures aimed at HIV treatment and viral load suppression, which eliminates risk of transmission. This study was prospectively registered on ClinicalTrials.gov, Identifier: NCT04108078, on September 27, 2019.

Introduction Past research shows that HIV self‐testing (HIVST) can increase testing and facilitate more HIV diagnoses relative to clinic testing. However, in the United States, the use of HIVSTs is limited due to concerns that those who use HIVST could be less likely to be linked to care. Methods From January 2019 to April 2022, we recruited 811 men who have sex with men (MSM) in the United States who tested infrequently using an online marketing campaign and randomized them 1:1:1 to receive one of the following every 3 months for a year: (1) text message reminders to get tested at a local clinic (control); (2) mailed HIVST kits with access to a free helpline (standard HIVST); and (3) mailed HIVST kits with counselling provided within 24 hours of opening a kit (eTest). Quarterly follow‐up surveys assessed HIV testing, sexually transmitted infection (STI) testing, pre‐exposure prophylaxis (PrEP) use and sexual risk behaviour. Findings Eight participants were diagnosed with HIV, and all but one were through HIVST. Participants in either HIVST condition, standard or eTest, had significantly higher odds of any testing (OR = 7.9, 95% CI = 4.9−12.9 and OR = 6.6, 95% CI = 4.2−10.5) and repeat testing (>1 test; OR = 8.5, 95% CI = 5.7−12.6; OR = 8.9, 95% CI = 6.1−13.4) over 12 months relative to the control group. Rates of STI testing and PrEP uptake did not differ across study condition, but those in the eTest condition reported 27% fewer sexual risk events across the study period relative to other groups. Conclusions HIVST vastly increased testing, encouraged more regular testing among MSM, and identified nearly all new cases, suggesting that HIVST could diagnose HIV acquisition earlier. Providing timely follow‐up counselling after HIVST did not increase rates of STI testing or PrEP use, but some evidence suggested that counselling may have reduced sexual risk behaviour. To encourage more optimal testing, programmes should incorporate HIVST and ship kits directly to recipients at regular intervals.

Testing infants at birth and with more efficient point of care (POC) HIV diagnostic can streamline EID and expedite infant ART initiation. We evaluated the implementation of at birth and 6-week POC testing to assess the effectiveness and feasibility when implemented by existing hospital staff in Kenya. Four government hospitals were randomly assigned to receive a GeneXpert HIV-1 Qual (n = 2) or Alere m-PIMA (n = 2) machine for POC testing. All HIV-exposed infants enrolled were eligible to receive POC testing at birth and 6-weeks of age. The primary outcome was repeat POC testing, defined as testing both at birth and 6-weeks of age. Secondary outcomes included predictors of repeat POC testing, POC efficiency (turnaround times of key services), and operations (failed POC results, missed opportunities). Of 626 enrolled infants, 309 (49.4%) received repeat POC testing, 115 (18.4%) were lost to follow up after an at-birth test, 120 (19.2%) received POC testing at 6-weeks only, 80 (12.8%) received no POC testing, and 2 (0.3%) received delayed POC testing (>12 weeks of age). Three (0.4%) were identified as HIV-positive. Of the total 853 POC tests run at birth (n = 424) or 6-weeks (n = 429), 806 (94.5%) had a valid result documented and 792 (98.3%) results had documented maternal notification. Mean time from sample collection to notification was 1.08 days, with 751 (94.8%) notifications on the same day as sample collection. Machine error rates at birth and 6-weeks were 8.5% and 2.5%, respectively. A total of 198 infants presented for care (48 at birth; 150 at 6-weeks) without receiving a POC test, representing missed opportunities for testing. At birth POC testing can streamline infant HIV diagnosis, expedite ART initiation and can be implemented by existing hospital staff. However, maternal disengagement and missed opportunities for testing must be addressed to realize the full benefits of at birth POC testing.