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Background: Bacterial vaginosis (BV), a disruption of the normal vaginal flora, has been associated with a 60% increased risk of HIV-1 acquisition in women and higher concentration of HIV-1 RNA in the genital tract of HIV-1-infected women. However, whether

Natasha Mack,1 Stella Kirkendale,1 Paul Omullo,2 Jacob Odhiambo,2 Malebo Ratlhagana,3 Martha Masaki,4 Phumzile Siguntu,5 Kawango Agot,2 Khatija Ahmed,3 Saidi Kapiga,4 Johan Lombaard,5 Lut Van Damme,1 Amy Corneli1 1FHI 360, Durham, NC, USA; 2Impact Research and Development Organization, Bondo, Kenya; 3Setshaba Research Centre, Soshanguve, South Africa; 4Kilimanjaro Christian Medical Center, Moshi, Tanzania; 5Josha Research, Bloemfontein, South Africa Abstract: Biomedical HIV-prevention research is most likely to succeed when researchers actively engage with community stakeholders. To this effect, the Joint United Nations Programme on HIV/AIDS and the AIDS Vaccine Advocacy Coalition developed good participatory practice guidelines for biomedical HIV-prevention trials in 2007 and updated them in 2011. The Preexposure Prophylaxis Trial for HIV Prevention among African Women (FEM-PrEP) clinical trial, testing once-daily Truvada as preexposure prophylaxis among women at higher risk of HIV in Kenya, South Africa, and Tanzania, included a community program to engage with local stakeholders. Following the trial, we revisited the community program to situate activities in the context of the 2011 guidelines. In the paper, we describe implementation of the six guidelines relevant to local stakeholder engagement – stakeholder advisory mechanisms, stakeholder engagement plan, stakeholder education plan, communications plan, issues management plan, trial closure, and results dissemination – in light of on-the-ground realities of the trial. We then identify two cross-cutting themes from our considerations: (1) stakeholder education beyond the good participatory practice recommendation to increase research literacy about the specific trial is needed; education efforts should also communicate a base of information on HIV transmission and prevention; and (2) anticipatory preparation is useful in communications planning, issues management, and trial closure and results dissemination, and may contribute to successful conduct of the trial; in FEM-PrEP, this was possible through integration of the community program with social, behavioral, and clinical research. Keywords: stakeholder engagement, community engagement, community involvement, HIV-prevention trials, good participatory practice guidelines, FEM-PrEP

The study attempts to evaluate whether a daily dose of acyclovir resulted in the suppression of herpes simplex virus type 2 (HSV-2) and led to a reduced risk of transmission of human immunodeficiency virus type 1 (HIV-1). The results indicate that such therapy was not effective in reducing the risk of HIV-1 even though it did lead to a 73% reduction in the occurrence of genital ulcers due to HSV-2.

Background: The COVID-19 pandemic has affected millions of people worldwide. This made it difficult for face-to-face data collection in ongoing research studies. Hence, innovative data collection methods are critical to avoid interruptions in critical research studies with vulnerable population to inform interventions and policy. The study was nested in the MAISHA cohort, a four-wave longitudinal study of 445 women on intimate partner violence in Mwanza, Tanzania. Objectives: To explore the impact of COVID-19 on women's physical, psychological, and economic wellbeing. We also investigated their experiences of Intimate Partner Violence (IPV). Methods: We conducted 18 phone based in-depth interviews with purposively sampled women. The interviews were audio-recorded and transferred to computers for analysis. In addition, we conducted longitudinal phone-based interviews with 445 women using a structured questionnaire. 443 (97%) of the women were re-interviewed after 3 months. Results: Participants reported no different experience of being interviewed by phone compared with face-to-face interviews. They were free to report sensitive information including their experience of COVID-19, IPV, and relationships with their intimate partners. The phone interview methodology was considered more private and time efficient. Interview lasted for 30-40 minutes. The method has additional advantages as it is reduces research costs from travel and ensures safety of both researchers and study participants. Challenges included audibility, unstable network, and unreachable phones. Conclusions: It is feasible to conduct mixed methods phone interviews in the Tanzanian setting. Researchers should explore using this method frequently to conduct longitudinal studies in the country. Training of research teams is crucial for the successful use of such methods. [ABSTRACT FROM AUTHOR]

Background: The incidence of human immunodeficiency virus (HIV) infection remains high among women in sub-Saharan Africa. We evaluated the safety and efficacy of extended use of a vaginal ring containing dapivirine for the prevention of HIV infection in 1959 healthy, sexually active women, 18 to 45 years of age, from seven communities in South Africa and Uganda.Methods: In this randomized, double-blind, placebo-controlled, phase 3 trial, we randomly assigned participants in a 2:1 ratio to receive vaginal rings containing either 25 mg of dapivirine or placebo. Participants inserted the rings themselves every 4 weeks for up to 24 months. The primary efficacy end point was the rate of HIV type 1 (HIV-1) seroconversion.Results: A total of 77 participants in the dapivirine group underwent HIV-1 seroconversion during 1888 person-years of follow-up (4.1 seroconversions per 100 person-years), as compared with 56 in the placebo group who underwent HIV-1 seroconversion during 917 person-years of follow-up (6.1 seroconversions per 100 person-years). The incidence of HIV-1 infection was 31% lower in the dapivirine group than in the placebo group (hazard ratio, 0.69; 95% confidence interval [CI], 0.49 to 0.99; P=0.04). There was no significant difference in efficacy of the dapivirine ring among women older than 21 years of age (hazard ratio for infection, 0.63; 95% CI, 0.41 to 0.97) and those 21 years of age or younger (hazard ratio, 0.85; 95% CI, 0.45 to 1.60; P=0.43 for treatment-by-age interaction). Among participants with HIV-1 infection, nonnucleoside reverse-transcriptase inhibitor resistance mutations were detected in 14 of 77 participants in the dapivirine group (18.2%) and in 9 of 56 (16.1%) in the placebo group. Serious adverse events occurred more often in the dapivirine group (in 38 participants [2.9%]) than in the placebo group (in 6 [0.9%]). However, no clear pattern was identified.Conclusions: Among women in sub-Saharan Africa, the dapivirine ring was not associated with any safety concerns and was associated with a rate of acquisition of HIV-1 infection that was lower than the rate with placebo. (Funded by the International Partnership for Microbicides; ClinicalTrials.gov number, NCT01539226 .). [ABSTRACT FROM AUTHOR]

An abstract of the conference paper "Analysis of HIV-1 gp120 quasispecies suggests high prevalence of intra-subtype recombination," by I. E. Kiwelu and colleagues is presented.

Background: Innovative prevention strategies for HIV-1 transmission are urgently needed. PRO2000 vaginal gel was efficacious against HIV-1 transmission in studies in macaques; we aimed to assess efficacy and safety of 2% and 0·5% PRO2000 gels against vaginal HIV-1 transmission in women in sub-Saharan Africa.Methods: Microbicides Development Programme 301 was a phase 3, randomised, double-blind, parallel-group trial, undertaken at 13 clinics in South Africa, Tanzania, Uganda, and Zambia. We randomly assigned sexually active women, aged 18 years or older (≥16 years in Tanzania and Uganda) without HIV-1 infection in a 1:1:1 ratio to 2% PRO2000, 0·5% PRO2000, or placebo gel groups for 52 weeks (up to 104 weeks in Uganda). Randomisation was done by computerised random number generator. Investigators and participants were masked to group assignment. The primary efficacy outcome was incidence of HIV-1 infection before week 52, which was censored for pregnancy and excluded participants without HIV-1 follow-up data or with HIV-1 infection at enrolment. HIV-1 status was established by rapid tests or ELISA at screening at 12 weeks, 24 weeks, 40 weeks, and 52 weeks, and confirmed in a central reference laboratory. The primary safety endpoint was an adverse event of grade 3 or worse. Use of 2% PRO2000 gel was discontinued on Feb 14, 2008, on the recommendation of the Independent Data Monitoring Committee because of low probability of benefit. This trial is registered at http://isrctn.org, number ISRCTN 64716212.Findings: We enrolled 9385 of 15 818 women screened. 2591 (95%) of 2734 participants enrolled to the 2% PRO2000 group, 3156 (95%) of 3326 in the 0·5% PRO2000 group, and 3112 (94%) of 3325 in the placebo group were included in the primary efficacy analysis. Mean reported gel use at last sex act was 89% (95% CI 86-91). HIV-1 incidence was much the same between groups at study end (incidence per 100 woman-years was 4·5 [95% CI 3·8-5·4] for 0·5% PRO2000 vs 4·3 [3·6-5·2] for placebo, hazard ratio 1·05 [0·82-1·34], p=0·71), and at discontinuation (4·7 [3·8-5·8] for 2% PRO2000 gel, 3·9 [3·0-4·9] for 0·5% PRO2000 gel, and 3·9 [3·1-5·0] for placebo gel). Incidence of the primary safety endpoint at study end was 4·6 per 100 woman-years (95% CI 3·9-5·4) in the 0·5% PRO2000 group and 3·9 (3·2-4·6) in the placebo group; and was 4·5 (3·7-5·5) in the 2% PRO2000 group at discontinuation.Interpretation: Although safe, 0·5% PRO2000 and 2% PRO2000 are not efficacious against vaginal HIV-1 transmission and are not indicated for this use.Funding: UK Department for International Development, UK Medical Research Council, European and Developing Countries Clinical Trials Partnership, International Partnership for Microbicides, and Endo Pharmaceuticals Solutions. [ABSTRACT FROM AUTHOR]

Introduction: Improving menstrual health among schoolgirls is essential to meeting the Sustainable Development Goals (SDGs) of good health and wellbeing (SDG 03), quality education (SDG 04), and gender equality (SDG 05). School participation and wellbeing among girls in low and middle-income countries are impacted by inadequate access to quality menstrual materials and WASH facilities, taboos around menstruation, and poor knowledge. Comprehensive evidence is needed to address these challenges and guide policy and practice., Methods: An assisted self-completed questionnaire was used to collect socio-demographic information, menstrual-related data, and school climate data from 486 girls in four mixed-gender government secondary schools in Mwanza, Tanzania. The mean (SD) of three Menstrual Practices and Needs Scale (MPNS-36) sub-scores were calculated. Specifically, the extent to which girls perceived needs for carrying and changing menstrual material in school (transport and school environment); washing and drying menstrual material (reuse needs); and privacy and drying menstrual material in school (reuse insecurity) were met. An ANOVA test compared MPNS scores for groups, and logistic regression examined the association between menstrual health and wellbeing outcomes (self-efficacy, menstrual anxiety, school attendance, and participation) and MPNS subscale scores., Results: The mean age of the 486 participants was 15.6 years (SD 1.3); 87% had started menstruating; the mean age at menarche was 14.2 years (SD 1.15). The majority (75%) of girls experienced pain during the last menstrual period, 39% had menstrual-related anxiety, and 16% missed at least one day of school due to menstruation. The mean MPNS subscale score (out of 3) for the reuse needs ranged from 1.0 to 2.1 across schools; 1.6 to 2.1 for reuse insecurity; and 0.9 to 1.8 for transport and school environment needs. The MPNS subscales had sufficient reliability (Cronbach alpha = 0.74 to 0.9). The subscales also had good construct validity with menstrual-related self-efficacy: higher scores for transport and school environment were associated with confidence to seek menstrual support, participate in class, and predict when periods were about to start., Conclusions: Schoolgirls have unmet needs related to transporting and using menstrual material in school, and these needs differed across schools in northern Tanzania. Menstrual-related pain remains a major reason for poor school attendance and participation. Interventions to address menstrual practice needs in schools are required and should include a strong pain management component., (© 2024. The Author(s).)

Background: In Tanzania, nearly half of ever-married women have experienced some form of intimate partner violence (IPV), yet little knowledge of IPV from the male perspective exists., Objective: To explore the role of essential healthy lifestyle factors, diet, sleep, and exercise, and their potential role in IPV perpetration., Methods: A cross-sectional survey was conducted with 1,002 young men (ages 18-24), 754 of which were in an intimate relationship in the previous year. The study took place in Mwanza, Tanzania and used multivariable logistic regression models to explore associations between male perpetration of IPV and diet, sleep, and exercise., Results: Six types of IPV perpetration were investigated separately and the prevalence of controlling behaviours (79.4%), economic abuse (30.6%), emotional abuse (47.3%), physical violence (16.4%), sexual violence (23.3%), and combined physical and/or sexual violence (32.1%) were obtained. Regular exercise demonstrated a protective effect for economic abuse perpetration; the chance of mildly active individuals perpetrating economic abuse was 38% less than their inactive counterparts ( p  = 0.003). Associations with sleep were varied and did not show a clear directional relationship. Diet, defined as poor food variety, was positively associated with every IPV type except physical violence and was significant in sexual violence perpetration (aOR:1.57, 95%CI:1.21-2.05)., Conclusions: The results from this study indicate that considering healthy lifestyle behaviours - diet, sleep, and exercise - in the design of intervention programmes may be beneficial in reducing IPV perpetration in Tanzania, and that they should be considered alongside previously established evidence-based risk factors.

Background: During adolescence, behaviours are initiated that will have substantial impacts on the individual's short-term and long-term health and well-being. However, adolescents rarely have regular contact with health services, and available services are not always appropriate for their needs. We co-developed with adolescents a health and well-being check-up programme (Y-Check). This paper describes the methods to evaluate the feasibility, acceptability, short-term effects and cost-effectiveness of Y-Check in three African cities., Method: This is a multi-country prospective intervention study, with a mixed-method process evaluation. The intervention involves screening, on-the-spot care and referral of adolescents through health and well-being check-up visits. In each city, 2000 adolescents will be recruited in schools or community venues. Adolescents will be followed-up at 4 months. The study will assess the effects of Y-Check on knowledge and behaviours, as well as clinical outcomes and costs. Process and economic evaluations will investigate acceptability, feasibility, uptake, fidelity and cost effectiveness., Ethics and Dissemination: Approval has been received from the WHO (WHO/ERC Protocol ID Number ERC.0003778); Ghana Health Service (Protocol ID Number GHS-ERC: 027/07/22), the United Republic of Tanzania National Institute for Medical Research (Clearance No. NIMR/HQ/R.8a/Vol.IX/4199), the Medical Research Council of Zimbabwe (Approval Number MRCZ/A/2766) and the LSHTM (Approval Numbers 26 395 and 28312). Consent and disclosure are addressed in the paper. Results will be published in three country-specific peer-reviewed journal publications, and one multicountry publication; and disseminated through videos, briefs and webinars. Data will be placed into an open access repository. Data will be deidentified and anonymised., Trial Registration Number: NCT06090006., Competing Interests: Competing interests: PB and VB are WHO staff members. The opinions expressed are theirs and do not necessarily represent the policies and positions of the WHO. The other authors declared no competing interests., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Engaging men has been established as central in addressing intimate partner violence. Yet few studies on intimate partner violence explored men's perspectives on what constitutes sexual violence in relationships only. To explore how men conceptualize sexual violence, we engaged a qualitative approach to unpack men's narratives of sexual IPV. The study was conducted in Mwanza, Tanzania using in-depth interviews with 30 married men. Men shared a broad spectrum of unacceptable behaviors that clearly or potentially connote sexual violence. Some of the acts were deemed to constitute sexual violence when directed to both men and women, while some were perceived as sexual violence when directed to women or men only. Threatened manhood underpinned men's conceptualization of sexual violence against them by their partners. Although a large part of men's narratives of sexual violence towards women seemed to challenge the common sexual scripts existing in patriarchal societies, some of their accounts indicated the persistence of traditional presumptions of masculine sexual entitlement. Our findings uncover additional dimensions of sexual violence that go beyond what is included in the current global frameworks, underscoring the critical need of giving people a voice in their local contexts in defining what sexual intimate partner violence entails for them. This may increase the likelihood of interventions becoming more acceptable and effective when targeting sexual violence, thereby contributing to reduced levels of sexual intimate partner violence., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.