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BackgroundThere is a pressing need to ensure that youth in high HIV prevalence settings are prepared for a safer sexual debut. Smartphone ownership is increasing dramatically in low-income and middle-income countries. Smartphone games that are appropriately grounded in behavioral theory and evidence-based practice have the potential to become valuable tools in youth HIV prevention efforts in Sub-Saharan Africa.ObjectiveTo pilot-test a theory-based, empirically grounded smartphone game for young Kenyans designed to increase age and condom use at first sex, aiming to establish directionality of effects on behavior change.MethodsTumaini (“hope for the future” in Swahili) is an interactive, narrative-based game grounded in social cognitive theory. A randomized controlled pilot study was conducted in Kisumu, Western Kenya, from April to June 2017 with 60 participants aged 11-14 (mean 12.7) years. Intervention arm participants (n=30) were provided with an Android smartphone with Tumaini installed on it and were instructed to play the game for at least 1 hour a day for 16 days; control arm participants (n=30) received no intervention. All participants completed a survey on behavioral mediators, delivered via an audio computer-assisted self-interview system at baseline (T1), post intervention (T2), and at 6 weeks postintervention (T3). The postintervention survey for intervention arm participants included questions eliciting feedback on the game. Intervention arm participants and their parents participated in 8 postintervention focus group discussions. Game log files were analyzed to calculate the length of exposure to the game. Behavioral survey data were analyzed using two-sample t tests to compare mean change from T1 to T2 and to T3 for intervention versus control arm participants. Descriptive statistics on game feedback questions were computed. Focus group transcripts were uploaded to MAXQDA software, where they were labeled with deductive and inductive codes. Data were analyzed thematically and compared across demographics.ResultsIntervention arm participants played Tumaini for a mean of approximately 27 hours. The intervention arm showed significant gains in sexual health-related knowledge and self-efficacy (both P<.001), behavioral intention for risk-avoidance strategies and sexual risk communication (P=.006), and overall survey scores (P<.001) compared with the control arm at T3. The postintervention survey revealed high subjective measures of the game’s value, relevance, and appeal. Focus groups identified a wide range of knowledge and skills the participants had gained, including setting goals and planning how to achieve them, which was perceived as a key motivator for avoiding or reducing risk.ConclusionsThe study supports the need for further research to assess the efficacy of the game-based intervention. If proven efficacious, smartphone games have the potential to dramatically increase the reach of culturally adapted behavioral interventions while ensuring fidelity to intervention design.Trial RegistrationC...

The HIV Prevention Trials Network 052 study enrolled serodiscordant couples. Index participants infected with human immunodeficiency virus reported no prior antiretroviral (ARV) treatment at enrollment. ARV drug testing was performed retrospectively using enrollment samples from a subset of index participants. ARV drugs were detected in 45 of 96 participants (46.9%) with an undetectable viral load, 2 of 48 (4.2%) with a low viral load, and 1 of 65 (1.5%) with a high viral load (P < .0001); they were also detected in follow-up samples from participants who were not receiving study-administered treatment. ARV drug testing may be useful in addition to self-report of ARV drug use in some clinical trial settings.

Summary Background Antiretroviral therapy (ART) non-adherence causes HIV treatment failure. Past behaviour might predict future behaviour; failing second-line ART could indicate ongoing risk for subsequent non-adherence. We aimed to find out whether a two-way mobile phone-based communication intervention would increase HIV treatment success by improving medication adherence. Methods We did a multinational, randomised controlled trial of patients at 17 sites in nine lower-income and middle-income countries in Africa, Asia, and the Americas. Patients aged 18 years and older, with HIV infection, and on second-line protease-inhibitor-based antiretroviral regimens, were randomly assigned (1:1) to either two-way mobile phone intervention plus standard of care (MPI + SOC) adherence support or standard-of-care alone (SOC). Our study was nested within a strategy study of ART after second-line ART failure (the main study, A5288). The main study had four cohorts, which were assigned regimens according to ART history and real-time genotype. Randomisation was stratified by the main study cohort with dynamic institutional balancing. Only the clinical management committee was masked, not the participants or site personnel. Text messages were sent over 48 weeks starting once a day and tapering down to once per week; participants were to respond once to each message if taking ART without issues. Repeated non-response to three messages over a 2-week period for the first 8 weeks, and then two messages over a 2-week period for the remainder of the study, triggered problem-solving counselling by staff. For this study, the primary endpoint was plasma HIV-1 RNA 200 copies per mL or less at 48 weeks and the secondary endpoint was virological failure (two consecutive HIV-1 RNA ≥1000 copies per mL) at 24 or more weeks. Prespecified intention-to- treat analyses were adjusted for cohort. Follow-up continued until the last participant had reached 48 weeks, with a median follow-up time of 72 weeks. The trial is registered with ClinicalTrials.gov, number . Findings Enrolment began on Feb 22, 2013, and ended on Dec 21, 2015, with the last participant completing follow-up on Feb 13, 2017. Of 545 participants in the main study, 521 (96%) were enrolled and randomly assigned to MPI + SOC (n=257) or SOC alone (n=264). 52% of patients were men and the median HIV-1 RNA 4–4 log10 copies per mL (IQR 3.5 to 5–2). At week 48, HIV-1 RNA 200 copies per mL or less was reached in 169 (66%) of 257 patients in the MPI + SOC group and 164 (62%) of 264 patients in the SOC group (estimated difference 3–6% [95% CI −4–6% to 11–9%]; p=0–39). The adjusted odds ratio comparing MPI + SOC and SOC was 1–23 (0–82 to 1–84; p=0–32). Virological failure occurred in 66 (26%) patients in the MPI + SOC group and 89 (34%) patients in the SOC group during the median 72 weeks follow-up (adjusted p=0–027). Observed difference in virological failure favoured MPI + SOC in all cohorts. 23 (4%) participants died, 11 (4%) in the MPI + SOC group and 12 (5%) in the SOC group (p=0–89...

Background Young people aged 15 to 24 years account for one-third of new adult HIV infections. Controlling the HIV epidemic requires effective interventions targeted toward young people and their needs. Smartphone games offer a promising avenue for reaching this population with evidence-based HIV prevention interventions. It is crucial to the effectiveness of these interventions that they be acceptable and intrinsically motivating to adolescents as well as acceptable to their parents. Objective Tumaini is a narrative-based smartphone game designed to help prevent HIV among young Africans aged 11 to 14 years by delaying first sex and increasing condom use at first sex. Following a 16-day feasibility study of Tumaini , we assessed the acceptability (1) of the intervention, where acceptability was operationalized as appeal, relevance, value, usability, and understandability, and (2) of this study and a planned future randomized controlled efficacy trial. Methods During the randomized feasibility study (n=60) of Tumaini in western Kenya in spring 2017, 30 participants used the intervention on a study-provided smartphone. The app automatically logged participant interaction with the game in time-stamped log files. All 30 participants completed an Audio Computer-Assisted Self-Interview–based game experience survey, and 27 took part in 4 focus group discussions (FGDs) about the game’s appeal, relevance, value, usability, and understandability. Their parents (n=22) also participated in 4 FGDs about the acceptability of the intervention, of this study, and of a planned efficacy trial. Survey data were analyzed using SAS software (SAS Institute Inc); FGD transcripts were coded and analyzed in MAXQDA 12 (Verbi GmbH); and gameplay log files were analyzed using Microsoft Excel. Results Adolescent participants’ survey responses indicated that Tumaini scored well with players on all indicators of acceptability (appeal, relevance, value, usability, and understandability). Focus group analyses aligned with these findings and emphasized a high degree of player engagement with the game, which was supported by log file analysis. Adolescent participants were eager for additional content, and parents were receptive to a longer study involving biomarkers, based on their positive experiences with this study. There is scope to improve communication with parents about their role in the intervention. As the game was tested in beta version, there is also scope to fine-tune some of the game mechanics to increase usability. Conclusions This study shows the strong acceptability of an interactive smartphone-based game both to adolescents and their parents in western Kenya and that of the study methods used to pilot-test the intervention. It also suggests that longitudinal efficacy studies of this type of intervention, i...

We conducted an exploratory analysis of former HIV Prevention Trials Network 052 (HPTN 052) clinical trial participants in 2016 to assess their (1) satisfaction with the HPTN 052 clinical trial care and treatment, and reasons for joining the trial; and (2) perspectives about the post-trial transition to public HIV care centers. Quantitative data showed that, of the 70 survey participants, 94.3% (n = 66) reported being very satisfied with the care and treatment they received while participating in the clinical trial and 51.4% (n = 36) reported they joined the study because they would receive information to improve their own or their partner's health. Qualitative data (five in-depth interviews and two focus group discussions) analysis revealed the following themes: transition experiences; perceived superior clinical trial care; study benefits not offered at public HIV care centers; and the public HIV care centers' indifference to the uninfected partner. For some HPTN 052 participants, transition to HIV care clinics was disappointing. Clinical trial investigators and local Institutional Review Boards should consider the need for safeguards and oversight of post-trial health care for trial participants after the trial ends, especially in resource-constrained settings, to avoid negative health outcomes.

Success of antiretroviral therapy depends on adherence to effective treatment. We evaluated four adherence methods and their correlation with immunological and virologic response among women receiving PMTCT. Univariable and multivariable analyses were used to assess how adherence by pill count (n = 463), self-report (n = 463), MEMS (n = 129) and plasma drug level (n = 89) was associated with viral load suppression within a 6 months period. Longitudinal analysis was performed to determine the correlation of CD4 cell count with each measure of adherence. For all measures of adherence, sustained viral suppression was less likely for participants in the lowest category of adherence. Although CD4 cell count increased substantially over time, there was no significant association with adherence by the methods. Multiple strategies can be used successfully to monitor treatment adherence. Persons with ≥95% adherence by any method used in this study were more likely to have a favorable treatment outcome.

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