Rachel Valencia

Background: Gestational diabetes mellitus (GDM) is linked with adverse health outcomes for both mother and infant and increases the risk of type 2 diabetes mellitus (T2DM) and long-term metabolic dysfunction postpartum. American Samoa experiences among the highest prevalence of GDM globally, with estimates suggesting 26–42% of women develop the condition. To date, no studies have attempted to understand the underlying etiology of GDM in Pacific Islanders or examine population-specific progression from GDM to T2DM. The GROW study will characterize glucose homeostasis, diabetes progression, and the impact of a Pacific-specific variant (rs373863828) in the CREBRF gene, which is known to protect against T2DM, on glucose metabolism during and after pregnancy. Methods: We will establish a prospective cohort study of 350 pregnant women in American Samoa, enrolled in their first trimester and followed through 18 months postpartum. Participants will be genotyped for CREBRF rs373863828 and undergo frequently-sampled oral glucose tolerance test (fs-OGTTs), glycated hemoglobin (HbA1c), and continuous glucose monitoring (CGM) measurements to identify glycemic patterns across the perinatal period. Participants will complete questionnaires assessing reproductive health history, diet, physical activity, sleep, and psychosocial health. We will examine associations between CREBRF genotype and glucose homeostasis across pregnancy and postpartum and evaluate risk of GDM and subsequent T2DM. We will also explore associations between CREBRF genotype, changes in insulin secretion in pregnancy, and risk of adverse birth outcomes. Discussion: Findings from this study are expected to inform precision medicine approaches to diabetes prevention, refine public health policies and clinical guidelines, and support community-based interventions aimed at reducing GDM and T2DM among Pacific Islander women and more broadly.

Background: There is an ongoing syndemic of HIV and sexually transmitted infections (STIs) in the United States, particularly among men who have sex with men (MSM). We have increasingly effective and diverse measures of prevention, including various types of pre-exposure prophylaxis (PrEP) for HIV prevention and doxycycline postexposure prophylaxis (doxyPEP) for STI prevention. As options expand, we need to understand how to use a combination of these strategies and other supports for MSM to best curb the syndemic. Objective: We designed a patient-preference trial to understand patient preferences for PrEP and doxyPEP, how preferences may change over time, and methods for preventing premature discontinuation of PrEP. Methods: We enrolled HIV-negative MSM in metropolitan Atlanta, Georgia. Participants could elect to take PrEP (daily or on-demand), doxyPEP, both, or neither, along with app-based support to evaluate for risk factors of discontinuation or behavioral changes that might affect their choice of prevention methods. Participants were able to switch prevention methods at any time. Oral PrEP and doxyPEP users are currently being offered quarterly in-person or at-home HIV, syphilis, gonorrhea, and chlamydia testing along with opportunities for motivational interviewing. Results: We enrolled individuals from November 2021 to September 2023. Among 240 participants, the median age was 30 (IQR 25-35), 63% (n=150) self-identified as non-Hispanic Black, and 69% (n=166) were insured. Most participants (n=144, 60%) elected to take daily PrEP plus doxyPEP, with a smaller proportion taking on-demand PrEP plus doxyPEP (n=34, 14%) or daily PrEP without doxyPEP (n=33, 14%). Conclusions: We designed an ongoing study to evaluate the preferences for PrEP and doxyPEP among MSM in metropolitan Atlanta. Enrollment was completed in 22 months and included a diverse cohort of MSM that will be followed longitudinally to evaluate prevention preferences over time. At baseline, most participants preferred to take a combination of daily PrEP and doxyPEP for HIV and STI prevention. Trial Registration: Clinicaltrials.gov NCT05072093; https://clinicaltrials.gov/study/NCT05072093 International Registered Report Identifier (IRRID): DERR1-10.2196/56096

BACKGROUND There is an ongoing syndemic of HIV and sexually transmitted infections (STIs) in the United States, particularly among men who have sex with men (MSM). We have increasingly effective and diverse measures of prevention, including various types of pre-exposure prophylaxis (PrEP) for HIV prevention and doxycycline postexposure prophylaxis (doxyPEP) for STI prevention. As options expand, we need to understand how to use a combination of these strategies and other supports for MSM to best curb the syndemic. OBJECTIVE We designed a patient-preference trial to understand patient preferences for PrEP and doxyPEP, how preferences may change over time, and methods for preventing premature discontinuation of PrEP. METHODS We enrolled HIV-negative MSM in metropolitan Atlanta, Georgia. Participants could elect to take PrEP (daily or on-demand), doxyPEP, both, or neither, along with app-based support to evaluate for risk factors of discontinuation or behavioral changes that might affect their choice of prevention methods. Participants were able to switch prevention methods at any time. Oral PrEP and doxyPEP users are currently being offered quarterly in-person or at-home HIV, syphilis, gonorrhea, and chlamydia testing along with opportunities for motivational interviewing. RESULTS We enrolled individuals from November 2021 to September 2023. Among 240 participants, the median age was 30 (IQR 25-35), 63% (n=150) self-identified as non-Hispanic Black, and 69% (n=166) were insured. Most participants (n=144, 60%) elected to take daily PrEP plus doxyPEP, with a smaller proportion taking on-demand PrEP plus doxyPEP (n=34, 14%) or daily PrEP without doxyPEP (n=33, 14%). CONCLUSIONS We designed an ongoing study to evaluate the preferences for PrEP and doxyPEP among MSM in metropolitan Atlanta. Enrollment was completed in 22 months and included a diverse cohort of MSM that will be followed longitudinally to evaluate prevention preferences over time. At baseline, most participants preferred to take a combination of daily PrEP and doxyPEP for HIV and STI prevention. CLINICALTRIAL Clinicaltrials.gov NCT05072093; https://clinicaltrials.gov/study/NCT05072093 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/56096

Background: Transmasculine people are at risk for HIV; yet few HIV prevention interventions have been developed for this population. We adapted an existing HIV prevention smartphone app for cisgender men who have sex with men to meet the sexual health needs of transmasculine people. Objective: This study aims to assess the acceptability of the adapted app, Transpire, among transmasculine people living in Atlanta, Georgia, and Washington, DC, via in-depth interviews of participants in a pilot feasibility trial. Methods: Participants used the Transpire app for 3 months as part of a pilot study of the app. Eligible participants were aged 18-34 years. There were no eligibility criteria with respect to race and ethnicity, and most participants were non-Hispanic White. At the end of the follow-up, participants were invited to participate in web-based in-depth interviews to discuss their experiences using the app and feedback on design and content. Interviews were transcribed and coded using a constant comparative approach. Three main themes were identified: sexual behavior, app experiences and feedback, and pre-exposure prophylaxis. Results: Overall, participants found the app acceptable and thought that it would be a useful tool for themselves and their peers. Participants reported appreciating having a comprehensive information source available to them on their phones and reported learning more about HIV, sexually transmitted infections, and pre-exposure prophylaxis via the app. They also reported appreciating the inclusive language that was used throughout the app. Although the app included some resources on mental health and substance use, participants reported that they would have appreciated more resources and information in these areas as well as more comprehensive information about other health concerns, including hormone therapy. Representative quotes are presented for each of the identified themes. Conclusions: There is a desire to have greater access to reliable sexual health information among transmasculine people. Mobile apps like Transpire are an acceptable intervention to increase access to this information and other resources. More evidence is needed, however, from more racially and ethnically diverse samples of transmasculine people.

BACKGROUND Transmasculine people are at risk for HIV; yet few HIV prevention interventions have been developed for this population. We adapted an existing HIV prevention smartphone app for cisgender men who have sex with men to meet the sexual health needs of transmasculine people. OBJECTIVE This study aims to assess the acceptability of the adapted app, Transpire, among transmasculine people living in Atlanta, Georgia, and Washington, DC, via in-depth interviews of participants in a pilot feasibility trial. METHODS Participants used the Transpire app for 3 months as part of a pilot study of the app. Eligible participants were aged 18-34 years. There were no eligibility criteria with respect to race and ethnicity, and most participants were non-Hispanic White. At the end of the follow-up, participants were invited to participate in web-based in-depth interviews to discuss their experiences using the app and feedback on design and content. Interviews were transcribed and coded using a constant comparative approach. Three main themes were identified: sexual behavior, app experiences and feedback, and pre-exposure prophylaxis. RESULTS Overall, participants found the app acceptable and thought that it would be a useful tool for themselves and their peers. Participants reported appreciating having a comprehensive information source available to them on their phones and reported learning more about HIV, sexually transmitted infections, and pre-exposure prophylaxis via the app. They also reported appreciating the inclusive language that was used throughout the app. Although the app included some resources on mental health and substance use, participants reported that they would have appreciated more resources and information in these areas as well as more comprehensive information about other health concerns, including hormone therapy. Representative quotes are presented for each of the identified themes. CONCLUSIONS There is a desire to have greater access to reliable sexual health information among transmasculine people. Mobile apps like Transpire are an acceptable intervention to increase access to this information and other resources. More evidence is needed, however, from more racially and ethnically diverse samples of transmasculine people.

The Southern African Journal of HIV Medicine is focused on HIV/AIDS treatment, prevention and related topics relevant to clinical and public health practice. The purpose of the journal is to disseminate original research results and support high-level learning related to HIV Medicine. It publishes original research articles, editorials, case reports/case series, reviews of state-of-the-art clinical practice and correspondence.

Introduction: Men who have sex with men (MSM) and transgender women (TGW) experience high incidence and prevalence of sexually transmitted infections (STI), and data are needed to understand risk factors for STIs in these populations. The Sibanye Health Project was conducted in Cape Town and Port Elizabeth, South Africa from 2015 to 2016 to develop and test a package of HIV prevention interventions for MSM and TGW. We describe the incidence, prevalence and symptoms of Chlamydia trachomatis (CT), Neisseria gonorrhea (NG) and syphilis observed during the study.Methods: Participants completed HIV testing at baseline. All participants who were HIV negative were followed prospectively. Additionally, a sample of participants identified as living with HIV at baseline was selected to be followed prospectively so that the prospective cohort was approximately 20% HIV positive; the remaining participants identified as HIV positive at baseline were not followed prospectively. Prospective participants were followed for 12 months and returned for clinic‐based STI/HIV testing and assessment of STI symptoms at months 6 and 12. Additional HIV/STI testing visits could be scheduled at participant request.Results: Following consent, a total of 292 participants attended a baseline visit (mean age = 26 years), and 201 were enrolled for the 12‐month prospective study. Acceptance of screening for syphilis and urethral NG/CT was near universal, though acceptance of screening for rectal NG/CT was lower (194/292; 66%). Prevalence of urethral CT and NG at baseline was 10% (29/289) and 3% (8/288) respectively; incidence of urethral CT and NG was 12.8/100 person‐years (PY) and 7.1/100 PY respectively. Prevalence of rectal CT and NG at baseline was 25% (47/189) and 16% (30/189) respectively; incidence of rectal CT and NG was 33.4/100 PY and 26.8/100 PY respectively. Prevalence of syphilis at baseline was 17% (45/258) and incidence was 8.2/100 PY. 91%, 95% and 97% of diagnosed rectal NG/CT, urethral NG/CT and syphilis infections, respectively, were clinically asymptomatic.Conclusions: Prevalence and incidence of urethral and rectal STIs were high among these South African MSM and TGW, and were similar to rates in other settings in the world. Clinical symptoms from these infections were rare, highlighting limitations of syndromic surveillance and suggesting the need for presumptive testing and/or treatment to address the STI epidemic among MSM/TGW in South Africa.

Introduction: Men who have sex with men (MSM) and transgender women (TGW) are at increased risk for acquiring HIV, but there are limited HIV incidence data for these key populations in Africa. Understanding HIV prevalence and incidence provides important context for designing HIV prevention strategies, including pre‐exposure prophylaxis (PrEP) programmes. We describe HIV prevalence, awareness of HIV infection, HIV incidence and associated factors for a cohort of MSM and TGW in Cape Town and Port Elizabeth, South Africa.Methods: From 2015 to 2016, MSM and TGW in Cape Town and Port Elizabeth were enrolled and prospectively followed for 12 months, receiving a comprehensive package of HIV prevention services. HIV testing was conducted at baseline and at follow‐up visits (targeted for three, six and twelve months). All HIV‐negative PrEP‐eligible participants were offered PrEP enrolment during the first four months of study participation. We determined HIV prevalence among participants at baseline, and incidence by repeat screening of initially HIV‐negative participants with HIV tests at three, six and twelve months.Results: Among 292 participants enrolled, HIV prevalence was high (43%; 95% CI: 38 to 49) and awareness of HIV status was low (50%). The 167 HIV‐negative participants who were followed prospectively for 144.7 person‐years; nine incident HIV infections were documented. Overall annual incidence was 6.2% (CI: 2.8 to 11.8) and did not differ by city. Annual HIV incidence was significantly higher for younger (18 to 19 years) MSM and TGW (MSM: 21.8% (CI: 1.2 to 100); TGW: 31.0 (CI: 3.7, 111.2)). About half of participants started PrEP during the study; the annual incidence of HIV among 82 (49%) PrEP starters was 3.6% (CI: 0.4, 13.1) and among those who did not start PrEP was 7.8% (CI: 3.1, 16.1).Conclusions: HIV incidence was high among MSM and TGW in the context of receiving a comprehensive package of prevention interventions and offering of PrEP. PrEP uptake was high; the observed incidence of HIV in those who started PrEP was about half the incidence of HIV in those who did not. Future implementation‐oriented studies should focus on decisions to start and continue PrEP for those at highest risk, including young MSM.

Background: The severe acute respiratory coronavirus 2 (SARS-CoV-2) pandemic calls for expanded opportunities for testing, including novel testing strategies such as home-collected specimens. Objective: We aimed to understand whether oropharyngeal swab (OPS), saliva, and dried blood spot (DBS) specimens collected by participants at home and mailed to a laboratory were sufficient for use in diagnostic and serology tests of SARS-CoV-2. Methods: Eligible participants consented online and were mailed a participant-collection kit to support collection of three specimens for SARS-CoV-2 testing: saliva, OPS, and DBS. Participants performed the specimen collection procedures during a telehealth video appointment while clinical observers watched and documented the suitability of the collection. The biological sufficiency of the specimens for detection of SARS-CoV-2 by reverse transcriptase–polymerase chain reaction and serology testing was assessed by laboratorians using visual inspection and quantification of the nucleic acid contents of the samples by ribonuclease P (RNase P) measurements. Results: Of the enrolled participants,153/159 (96.2%) returned their kits, which were included in this analysis. All these participants attended their video appointments. Clinical observers assessed that of the samples collected, 147/153 (96.1%) of the saliva samples, 146/151 (96.7%) of the oropharyngeal samples, and 135/145 (93.1%) of the DBS samples were of sufficient quality for submission for laboratory testing; 100% of the OPS samples and 98% of the saliva samples had cycle threshold values for RNase P <30, indicating that the samples contained sufficient nucleic acid for RNA-PCR testing for SARS-CoV-2. Conclusions: These pilot data indicate that most participant-collected OPS, saliva, and DBS specimens are suitable and sufficient for testing for SARS-CoV-2 RNA and serology. Clinical observers rated the collection of specimens as suitable for testing, and visual and quantitative laboratory assessment indicated that the specimens were biologically sufficient. These data support the utility of participant-collected and mailed-in specimens for SARS-CoV-2 testing. International Registered Report Identifier (IRRID): RR2-10.2196/19054