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Background: The HIV epidemiology in South Africa reveals stark age and gender disparities, with young women being the most vulnerable to HIV acquisition in 2017. Evaluation of HIV exposure is a challenge in HIV prevention research. Intermittent in-clinic interviewer-administered risk behaviour assessments are utilised but may be limited by social desirability and recall biases. We piloted a mobile phone application for daily self-report of sexual risk behaviour in fifty 18–25 year old women at risk of HIV infection enrolled in HIV Vaccine Trials Network 915 (HVTN 915) in Soweto, South Africa. Through a mixed-methods investigation, we explored barriers and facilitators to completing daily mobile phone surveys among HVTN 915 study participants and staff. Methods: We analysed quantitative data on barriers and facilitators to mobile phone study completion collected during the larger HVTN 915 study as well as two post-study focus group discussions (FGDs) with fifteen former participants with a median age of 24 years (IQR 23–25) and six individual in-depth interviews (IDIs) with HVTN 915 staff. FGDs and IDIs utilised semi-structured interview guides, were audio-recorded, transcribed verbatim and translated to English. After coding, thematic analysis was performed. Results: The main facilitator for daily mobile phone survey completion assessed across 336 follow-up visits for 49 participants was the daily short message system (SMS) reminders (93%, 312/336). Across 336 visits, 31/49 (63%) retained participants reported barriers to completion of daily mobile phone surveys: forgetting (20%, 12/49), being too busy (19%, 11/49) and the survey being an inconvenience (15%, 9/49). Five main themes were identified during the coding of IDIs and FGDs: (1) facilitators of mobile phone survey completion, such as daily SMS reminders and follow up calls for non-completers; (2) barriers to mobile phone survey completion, including partner, time-related and technical barriers; (3) power of incentives; (4) response bias in providing sensitive information, and (5) recommendations for future mobile phone based interventions. Conclusion: Despite our enthusiasm to use innovation to optimise sexual risk assessments, technical and practical solutions are required to improve implementation. We recommend further engagement with participants to optimise this approach and to further understand social desirability bias and study incentives in sexual risk reporting. [ABSTRACT FROM AUTHOR]

Recall and social desirability bias undermine self-report of paper-and-pencil questionnaires. Mobile phone questionnaires may overcome these challenges. We assessed and compared sexual risk behavior reporting via in-clinic paper-and-pencil and mobile phone questionnaires. HVTN 915 was a prospective cohort study of 50 adult women in Soweto, who completed daily mobile phone, and eight interviewer-administered in-clinic questionnaires over 12 weeks to assess sexual risk. Daily mobile phone response rates were 82% (n = 3486/4500); 45% (n = 1565/3486) reported vaginal sex (median sex acts 2 (IQR: 1-3)) within 24 h and 40% (n = 618/1565) consistent condom. Vaginal sex reporting was significantly higher via mobile phone across all visits (p < 0.0001). There was no significant difference in condom use reporting by mobile phone and in-clinic paper-based questionnaires across all visits (p = 0.5134). The results show high adherence and reporting of sex on the mobile phone questionnaire. We demonstrate feasibility in collecting mobile phone sexual risk data. [ABSTRACT FROM AUTHOR]

Background: The safety and immunogenicity of a vaccine regimen consisting of a 6-plasmid HIV-1 DNA prime (envA, envB, envC, gagB, polB, nefB) boosted by a recombinant adenovirus serotype-5 (rAd5) HIV-1 with matching inserts was evaluated in HIV-seronegative participants from South Africa, United States, Latin America and the Caribbean Methods: 480 participants were evenly randomized to receive either: DNA (4 mg IM by Biojector) at 0, 1 and 2 months, followed by rAd5 (1010 PU IM by needle/syringe) at 6 months; or placebo. Participants were monitored for reactogenicity and adverse events throughout the 12-month study. Peak and duration of HIV-specific humoral and cellular immune responses were evaluated after the prime and boost Results: The vaccine was well tolerated and safe. T-cell responses, detected by interferon-&ggr;(IFN-&ggr;) ELISpot to global potential T-cell epitopes (PTEs) were observed in 70.8% (136/192) of vaccine recipients overall, most frequently to Gag (54.7%) and to Env (54.2%). In U.S. vaccine recipients T-cell responses were less frequent in Ad5 sero-positive versus seronegative vaccine recipients (62.5% versus 85.7% respectively, p = 0.035). The frequency of HIV-specific CD4+ and CD8+ T-cell responses detected by intracellular cytokine staining were similar (41.8% and 47.2% respectively) and most secreted $2 cytokines. The vaccine induced a high frequency (83.7%-94.6%) of binding antibody responses to consensus Group M, and Clades A, B and C gp140 Env oligomers. Antibody responses to Gag were elicited in 46% of vaccine recipients Conclusion: The vaccine regimen was well-tolerated and induced polyfunctional CD4+ and CD8+ T-cells and multi-clade anti-Env binding antibodies [ABSTRACT FROM AUTHOR]