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Randomised placebo-controlled trials have shown that daily oral pre-exposure prophylaxis (PrEP) with tenofovir–emtricitabine reduces the risk of HIV infection. However, this benefit could be counteracted by risk compensation in users of PrEP. We did the PROUD study to assess this effect. PROUD is an open-label randomised trial done at 13 sexual health clinics in England. We enrolled HIV-negative gay and other men who have sex with men who had had anal intercourse without a condom in the previous 90 days. Participants were randomly assigned (1:1) to receive daily combined tenofovir disoproxil fumarate (245 mg) and emtricitabine (200 mg) either immediately or after a deferral period of 1 year. Randomisation was done via web-based access to a central computer-generated list with variable block sizes (stratified by clinical site). Follow-up was quarterly. The primary outcomes for the pilot phase were time to accrue 500 participants and retention; secondary outcomes included incident HIV infection during the deferral period, safety, adherence, and risk compensation. The trial is registered with ISRCTN (number ISRCTN94465371) and ClinicalTrials.gov (NCT02065986). We enrolled 544 participants (275 in the immediate group, 269 in the deferred group) between Nov 29, 2012, and April 30, 2014. Based on early evidence of effectiveness, the trial steering committee recommended on Oct 13, 2014, that all deferred participants be offered PrEP. Follow-up for HIV incidence was complete for 243 (94%) of 259 patient-years in the immediate group versus 222 (90%) of 245 patient-years in the deferred group. Three HIV infections occurred in the immediate group (1·2/100 person-years) versus 20 in the deferred group (9·0/100 person-years) despite 174 prescriptions of post-exposure prophylaxis in the deferred group (relative reduction 86%, 90% CI 64–96, p=0·0001; absolute difference 7·8/100 person-years, 90% CI 4·3–11·3). 13 men (90% CI 9–23) in a similar population would need access to 1 year of PrEP to avert one HIV infection. We recorded no serious adverse drug reactions; 28 adverse events, most commonly nausea, headache, and arthralgia, resulted in interruption of PrEp. We detected no difference in the occurrence of sexually transmitted infections, including rectal gonorrhoea and chlamydia, between groups, despite a suggestion of risk compensation among some PrEP recipients. In this high incidence population, daily tenofovir–emtricitabine conferred even higher protection against HIV than in placebo-controlled trials, refuting concerns that effectiveness would be less in a real-world setting. There was no evidence of an increase in other sexually transmitted infections. Our findings strongly support the addition of PrEP to the standard of prevention for men who have sex with men at risk of HIV infection. MRC Clinical Trials Unit at UCL, Public Health England, and Gilead Sciences.

This study tested a mobile health (mHealth) intervention program entitled WeTest, delivered via the WeChat mobile app, to promote oral HIV self-testing (HIVST) among MSM in Hefei, China. A total of 100 MSM participants enrolled, completed baseline assessment, were randomly assigned to intervention or control, and completed 6-month follow-up surveys. Intervention participants (n = 50) received two oral HIVST kits and access to WeTest, a private WeChat group which provided app-based messages and referrals to health services related to HIV. Control participants (n = 50) received two oral HIVST kits only. All participants received instructions to upload photographic results of their oral HIVST, which were sent to the project counselor via a secure WeChat online portal; immediate contact and referrals were made to any participants who tested HIV-positive. In GEE analyses adjusting for time effects and baseline confounders, intervention participants had significantly higher rates of HIV testing (adjusted rate ratio RR = 1.99, 95% confidence interval (CI) 1.07–3.84) and, in particular, higher rates of testing via oral HIVST (adjusted RR = 2.17, 95% CI 1.08–4.37) compared with the control group. Significant time effects were also found such that all participants, regardless of group allocation, had significantly higher rates of reporting consistent condom use with main partners (adjusted RR = 18.13, 95% CI 5.19–63.31) and with non-main partners (adjusted RR = 5.33, 95% CI 2.35–12.08). Findings from this study provide evidence for the feasibility, acceptability and preliminary effects of this mHealth approach to promoting oral HIVST among MSM in China.

ObjectiveTo carry out a randomised controlled trial on the effect of a new method of health promotion—email and mobile phone text messages (short messaging service (SMS))—on young people's sexual health.Methods994 people aged 16–29 were recruited at a music festival to a non-blinded randomised controlled trial. Participants were randomised to either receive sexual health promotion messages (n=507) or the control group (n=487). The 12-month intervention included SMS (catchy sexually transmissible infections prevention slogans) and emails. Participants completed questionnaires at the festival at baseline and online after 3, 6 and 12 months. Outcomes were differences between the control and intervention groups in health-seeking behaviour, condom use with risky partners (new or casual partners or two or more partners within 12 months) and STI knowledge.Results337 (34%) completed all three follow-up questionnaires and 387 (39%) completed the final questionnaire. At 12 months, STI knowledge was higher in the intervention group for both male (OR=3.19 95% CI 1.52 to 6.69) and female subjects (OR=2.36 95% CI 1.27 to 4.37). Women (but not men) in the intervention group were more likely to have had an STI test (OR=2.51, 95% CI 1.11 to 5.69), or discuss sexual health with a clinician (OR=2.92, 95% CI 1.66 to 5.15) than their control counterparts. There was no significant impact on condom use. Opinions of the messages were favourable.ConclusionThis simple intervention improved STI knowledge in both sexes and STI testing in women, but had no impact on condom use. SMS and email are low cost, popular and convenient, and have considerable potential for health promotion.Clinical trial registration numberAustralian Clinical Trials Registry - ACTRN12605000760673.

Background Youth in southern Africa continue to be at high risk of HIV infection. We investigated the awareness of, access to, and uptake of HIV prevention interventions (pre-exposure prophylaxis (PrEP), post-exposure prophylaxis (PEP), voluntary medical male circumcision and condoms) among youth in Zimbabwe. Methods A population-based survey of youth aged 18–24 years in 24 communities across three provinces was conducted between October 2021 and June 2022. An interviewer-administered questionnaire collected sociodemographic and sexual behaviour data including awareness of, access to, and use of HIV preventative interventions. Data were analysed using descriptive statistics and mixed-effects logistic regression weighted for clustering. Results We recruited 17,682 youth (60.8% female, median age 20 years (Interquartile range 19–22)). Altogether 46.8% ( n  = 3634) of unmarried youth and 5.6% ( n  = 3538) of married youth reported consistent condom use and 49.8% ( n  = 3369) of men reported being circumcised. Awareness of PrEP and PEP was 11.2% and 11.9% respectively. 6900 participants (38.4%) reported at least one eligibility criterion for PrEP. Eligibiltiy criteria included having multiple partners or receiving money or goods for sex in the last year, HIV-negative individuals in serodiscordant relationships, those who had ever been treated for an STI, ever injected drugs, been pregnant or taken PEP. In comparison to the non-eligible population ( n  = 10782), the eligible population were more likely to have heard of PrEP (13.5% vs. 9.9%, p  < 0.001), been offered PrEP if they had heard of it (17.0% vs. 6.3%, p  < 0.001) and to have ever taken PrEP if offered it (60.7% vs. 27.0%, p  < 0.001). Those in the richest wealth quintiles and with higher education level were more likely to have heard of PrEP and report regular condom use. Forty-two of 199 (20.2%) who reported having experienced forced sex in the last year sought healthcare afterwards, of these 17 of 42 (36.0%) had been offered PEP and 12 of 17 (63.7%) had ever taken it. Conclusions Use of HIV preventive interventions remains limited among youth despite longstanding HIV programmes. Lack of awareness limits use of PrEP and PEP. There are underlying socioeconomic barriers limiting awareness of and demand for condoms, circumcision and pharmacological prophylaxis. These must be urgently addressed. Trial registration number NCT03719521.

HIV prevention through pre-exposure prophylaxis (PrEP) may encourage riskier sexual behaviours that undermine the protection afforded by PrEP and generate negative spillovers through sexually transmitted infections (STIs). Tests for such risk compensatory behaviour in high-risk populations, such as female sex workers (FSWs), are lacking. This study aims to assess whether risk compensatory behaviours were observed among FSWs in Senegal after the rollout of PrEP. In a randomised controlled trial with a Zelen design, we stratified FSWs in Dakar (Senegal) by self-reported sexual risk-taking and prior PrEP experience and randomly assigned them to immediate referral for oral PrEP (Treatment) from 7 September 2021 to end January 2022 or delayed PrEP referral (Control). We compared outcomes 3-8 months after the referral of the treatment group and before the referral of the control group. Primary outcomes were self-reported condom use with clients and perceived HIV/STI risks from sex with clients with and without a condom. The analysis is a modified intention-to-treat analysis. We estimated effects of PrEP referral as well as effects of oral PrEP use induced by randomised assignment to active PrEP referral. Out of 500 individuals randomised, 308 (61.6%) were included in the analysis (Treatment: 182/300 = 60.7%; Control: 126/200 = 63%). PrEP referral increased the probability of using oral PrEP by 34.5 percentage points (pp) (95% CI [25.4, 43.6]; p < 0.001). Estimated effects of PrEP referral and PrEP use on condom use with the last client were positive but not statistically significantly different from zero. PrEP referral was estimated to increase the probability of condom use with all of the last three clients by 11.0 pp (95% CI [0.8, 21.2]; p = 0.034). PrEP use was estimated to increase this probability by 25.8 pp (95% CI [5.2, 46.4]; p = 0.014). Main limitations were low power, high attrition, self-reported outcomes and a limited follow-up period. This study, conducted in one location, did not find evidence that PrEP referral or oral PrEP use increased self-reported risky sex behaviours of FSWs within 3-8 months. The robustness of this finding needs to be tested with larger cohorts followed for longer periods in other settings, and using survey instruments that allow further examination of whether PrEP users are more likely to overreport condom use. ISRCTN-The UK's Clinical Study Registry, ISRCTN16445862 https://www.isrctn.com/ISRCTN16445862.

Youth experiencing homelessness (YEH) face challenges that increase their susceptibility to HIV/STIs. Nurse case management is effective in managing the complex needs of populations experiencing homelessness and reducing HIV risk. A randomized wait-list control study conducted between September 2019 to May 2023 evaluated the CAYA “Come As You Are” intervention. This nurse-led HIV prevention for YEH aged 16–25 years focused on the uptake of HIV prevention methods: pre- and post-HIV exposure prophylaxis (PrEP, nPEP), HIV/STI testing and treatment, sober sex, and condom use. Secondarily, we examined intervention impact on housing stability. Descriptive statistics were calculated by study arm. Multiple imputation (m = 10) was used for missing values and intervention effects were estimated from Bayesian multilevel models with noninformative priors. Participants ( N  = 450) were 21.1 years old on average, 62% Black, 11% Hispanic, 11% White, and 10% other race and reported being homeless for an average of 3 years. An intervention effect was found for PrEP use, which showed a larger increase from baseline to first follow-up (OR = 3.27; 95% Cr.I.: 1.13 to 10.14). No intervention impact was found for nPEP use, HIV and STI cases, sober sex, or condom use. Sheltering arrangements improved from baseline to the first follow-up in both groups with increase in shelter stability (OR = 3.85; 95% Cr.I.: 1.61 to 10.30) and decreased shelter transiency (OR = 0.29; 95% Cr.I.: 0.14 to 0.60). This study demonstrates that a personalized, nurse-led HIV prevention approach increased uptake of some but not all HIV prevention strategies among YEH. Clinical Trial Registration number NCT03910218.

This paper evaluates an experiment in which individuals in rural Malawi were randomly assigned monetary incentives to learn their HIV results after being tested. Distance to the HIV results centers was also randomly assigned. Without any incentive, 34 percent of the participants learned their HIV results. However, even the smallest incentive doubled that share. Using the randomly assigned incentives and distance from results centers as instruments for the knowledge of HIV status, sexually active HIV-positive individuals who learned their results are three times more likely to purchase condoms two months later than sexually active HIV-positive individuals who did not learn their results; however, HIV-positive individuals who learned their results purchase only two additional condoms than those who did not. There is no significant effect of learning HIV-negative status on the purchase of condoms.

Objectives. To evaluate the efficacy of an interactive, Web-based sexual health program (Health Education and Relationship Training [HEART]) for developing sexual assertiveness skills and enhancing sexual decision-making in adolescent girls. Methods. Participants were 222 tenth-grade girls (mean age = 15.2; 38% White, 29% Hispanic, 25% Black) in the Southeastern United States who were randomized in fall 2015 to the HEART intervention or an attention-matched control. We assessed participants at pretest, immediate posttest, and 4-month follow-up. Results. Both groups had similar demographic and sexual behavior characteristics at pretest. At immediate posttest, girls who completed the HEART program demonstrated better sexual assertiveness skills measured with a behavioral task, higher self-reported assertiveness, intentions to communicate about sexual health, knowledge regarding HIV and other sexually transmitted diseases (STDs), safer sex norms and attitudes, and condom self-efficacy compared with the control condition. At 4-month follow-up, group differences remained in knowledge regarding HIV and other STDs, condom attitudes, and condom self-efficacy. Conclusions. This brief online sexual health program can improve short-term outcomes among adolescent girls and offers an exciting new option in the growing array of digital health interventions available to youths. Trial Registration Number. NCT02579135.

BackgroundIncreasing rates of sexually transmitted infections (STIs) and antimicrobial resistance among young people underscore the urgent need for preventative interventions. Interventions should be evidence-based and tailored to the unique risks and needs associated with varying age, sex and sexual orientation. We used data from the Safetxt trial to explore whether young people’s age, sex and sexual orientation influence (1) their risk of STI reinfection and condom use and (2) the effect of the Safetxt intervention on STI reinfection and condom use.MethodsWe conducted exploratory secondary analyses of data from the Safetxt trial that evaluated a theory-based digital sexual health intervention tailored according to sex and sexual orientation. We recruited 6248 young people with STIs from 92 UK sexual health clinics and assessed outcomes after 1 year, including the cumulative incidence of STI reinfection and condom use at last sex. We used adjusted logistic regression and margins plots to visualise effect modification.ResultsThere were differences in STI reinfection and condom use by age, sex and sexuality. Age was associated with STI reinfection (OR 0.90, 95% CI 0.87 to 0.94) with evidence for interaction between age and sexuality (p<0.001). Our findings suggest that the risk of STI reinfection decreases with age among young heterosexuals but increases among men-who-have-sex-with-men (MSM). Overall, MSM had the highest likelihood of reinfection (OR 3.53, 95% CI 2.66 to 4.68) despite being more likely to use condoms (OR 1.50, 95% CI 1.18 to 1.91).Among MSM, age modified the intervention effect on condom use at 1 year with highest benefits among participants aged 16–18, moderate to minor benefits among those aged 18–21 and no effect among participants aged 22–24 years.ConclusionsFuture digital health interventions tailored for diverse sexuality groups need to target young people early enough to have an impact on sexual behaviour. Specific novel interventions are needed for older MSM.Trial registration number ISRCTN64390461.

Sexually transmitted infections (STIs) such as chlamydia are common among young people and can lead to serious health issues if untreated. Although condoms are recommended for prevention, many young people report inconsistent use during penetrative sex. Web-based STI testing is becoming increasingly popular, but these services typically offer minimal support or guidance on preventing future infections. The \"Wrapped\" intervention aims to help young users of web-based STI testing use condoms consistently and correctly during penetrative sex, thus reducing future STI incidence. This study aims to assess whether and how it is possible to conduct a future randomized controlled trial (RCT) of the Wrapped intervention. Users of web-based STI testing aged 16 years to 24 years were randomized to an online, double-blind, 2-arm, parallel-group feasibility RCT in which Wrapped plus usual care (basic information on STIs and condom use) was tested against usual care alone. Main outcome measures were the proportion of the sampling pool recruited and return of valid chlamydia self-samples at month (M)12. Other outcome measures included return of valid chlamydia self-samples at M3; online survey completion at baseline, M3, M6, and M12; follow-up by demographic characteristics; and acceptability of intervention and measures. Over 31weeks, 173 participants were recruited and provided a baseline chlamydia test result, representing 1.5% of the sampling pool (173/11,413; intervention: n=84; control: n=89). A valid chlamydia self-sample was returned by 75.7% (131/173; 95% CI 68.6-81.9) at M12. Therefore, 3574 participants, derived from a sampling pool of 238,266 service users, were estimated to be necessary to power a future full trial. Return of other follow-up measures included 75.1% (130/173) valid M3 chlamydia self-samples, 91.3% (158/173) M3 survey, 90.8% (157/173) M6 survey, and 90.8% (159/173) M12 survey. Participants at M12 appeared to broadly represent individuals in the sampling pool with some exceptions: a tendency for over-representation of participants who were older (20-24 years), of Black ethnicity, and in the least deprived quintile and under-representation of participants who were younger (16-19 years), male, and in deprivation quintile three. There was some evidence that attrition was patterned by ethnicity and age in ways that compounded initial recruitment patterns. Drop-out attrition was evident, with retention higher at M12 for the intervention group (72/84, 86%) than the control group (59/89, 66%). Eleven adverse events relating to participation were reported. A priori criteria for success were met. A full trial is feasible. Although the recruitment rate was low, the high volume of young people using web-based STI testing services (approximately 585,000 annually based on the latest data) provides a sufficient pool to meet the required sample size. To ensure balanced representation, strategies to address potential under- and over-representation of certain demographic subgroups by M12 should be implemented. ISRCTN Registry ISRCTN17478654; http://www.isrctn.com/ISRCTN17478654. RR2-10.2196/43645.