Correlation between gender-based violence and poor treatment outcomes among transgender women living with HIV in Brazil.

BACKGROUND: Transgender women are disproportionately affected by both HIV and gender-based violence (GBV), defined as physical, sexual, or emotional violence perpetrated against an individual based on their gender identity/expression. While a growing body of evidence demonstrates that GBV leads to poor HIV care and treatment outcomes among cisgender women, less research has examined this association among transgender women. We assessed the impact of lifetime experiences of GBV on subsequent retention in HIV care and laboratory confirmed viral suppression among a sample of transgender women living with HIV (TWH) in Brazil. METHODS: A pilot trial of a peer navigation intervention to improve HIV care and treatment among TWH was conducted in São Paulo, Brazil between 2018 and 2019. TWH were recruited and randomized into the intervention or control arm and participated in a baseline and 9-month follow-up survey and ongoing extraction of clinical visit, prescribing, and laboratory data. Generalized linear model regressions with a Poisson distribution estimated the relative risk (RR) for the association of lifetime physical and sexual violence reported at baseline with treatment outcomes (retention in HIV care and viral suppression) at follow-up, adjusting for baseline sociodemographic characteristics. RESULTS: A total of 113 TWH participated in the study. At baseline, median age was 30 years, and the prevalence of lifetime physical and sexual violence was 62% and 45%, respectively. At follow-up, 58% (n = 66/113) were retained in care and 35% (n = 40/113) had evidence of viral suppression. In adjusted models, lifetime physical violence was non-significantly associated with a 10% reduction in retention in care (aRR: 0.90, 95% CI: 0.67, 1.22) and a 31% reduction in viral suppression (aRR: 0.69; 95% CI: 0.43, 1.11). Lifetime sexual violence was non-significantly associated with a 28% reduction in retention in HIV care (aRR: 0.72, 95% CI: 0.52, 1.00) and significantly associated with a 56% reduction in viral suppression (aRR: 0.44; 95% CI: 0.24, 0.79). CONCLUSION: Our findings are among the first to demonstrate that lifetime experiences with physical and sexual violence are associated with poor HIV outcomes over time among transgender women. Interventions seeking to improve HIV treatment outcomes should assess and address experiences of GBV among this population. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03525340.

Cost Analysis of Short Messaging Service and Peer Navigator Interventions for Linking and Retaining Adults Recently Diagnosed With HIV in Care in South Africa.

INTRODUCTION: Large proportions of people living with HIV (PLHIV) in sub-Saharan Africa are not linked to or retained in HIV care. There is a critical need for cost-effective interventions to improve engagement and retention in care and inform optimal allocation of resources. METHODS: We estimated costs associated with a short message service (SMS) plus peer navigation (SMS+PN) intervention; an SMS-only intervention; and standard of care (SOC), within the I-Care cluster-randomized trial to improve HIV care engagement for recently diagnosed PLHIV. We employed a uniform cost data-collection protocol to quantify resources used and associated costs for each intervention. RESULTS: Compared with SOC, the SMS+PN intervention cost $1284 ($828-$2859) more per additional patient linked to care within 30 days and $1904 ($1158-$5343) more per additional patient retained in care at 12 months, while improving linkage by 24% (95% CI: 11 to 36) and retention by 16% (95% CI: 6 to 26). By contrast, the SMS-only intervention cost $198 ($93-dominated) more per additional patient linked to care and $697 ($171-dominated) more per additional patient retained in care but was not significantly associated with improvements in linkage (12%; 95% CI: -1 to 25) or retention (3%; 95% CI: -7 to 14) compared with SOC. The efficiency of the SMS+PN intervention could be improved by 46%, to $690 more per additional patient linked and $1023 more per additional patient retained in care, if implemented within the Department of Health using more efficient distribution of staff resources. DISCUSSION: Findings suggest that scale-up of the SMS+PN intervention could benefit patients, improving care and health outcomes while being cost-effective.

Factors associated with the retention of travestis and transgender women living with HIV in a peer navigation intervention in São Paulo, Brazil. / Fatores associados à retenção de travestis e mulheres trans vivendo com HIV em uma intervenção com navegação de pares em São Paulo, Brasil.

Travestis and transgender women (TrTGW) constitute the groups with the highest HIV prevalence in the world, with higher probability of infection compared with the general population and lower adherence to prevention and treatment strategies than other vulnerable groups. Considering these challenges, this study describes the factors associated with the retention of TrTGW with HIV to the TransAmigas project. Participants were recruited from April 2018 to September 2019 in a public health service in São Paulo, Brazil. A total of 113 TrTGW were randomly assigned to either a peer navigation intervention (75) or a control group (38) and followed up for nine months. To analyze the association between the selected variables and the outcome ("retention at nine months", regardless of contact at three months, defined by the "full completion of the final questionnaire"), bivariate and multivariate logistic regression models were used. Peer contact forms were qualitatively assessed to validate and complement the previous selection of quantitative component variables. Of the 113 participants, 79 (69.9%) participated in the interview after nine months, of which 54 (72%) were from the intervention group and 25 (66%) from the control group. In the final multivariate model, contact at three months (adjusted odds ratio - aOR = 6.15; 95% confidence interval - 95%CI: 2.16-17.51) and higher schooling level (≥ 12 years) (aOR = 3.26; 95%CI: 1.02-10.42) remained associated with the outcome, adjusted by race/skin color, age ≤ 35 years, and HIV serostatus disclosure. Future studies with TrTGW should include contact at regular intervals, with additional efforts aimed at participants with lower schooling level.

Travestis e mulheres trans (TrMT) pertencem aos grupos com mais alta prevalência do HIV no mundo, com maior probabilidade de infecção em relação à população geral e menor adesão a estratégias de prevenção e tratamento do que outros grupos vulneráveis. Considerando esses desafios, descrevemos os fatores associados à retenção de TrMT com HIV no projeto TransAmigas. O recrutamento ocorreu entre abril de 2018 e setembro de 2019, em um serviço público de saúde em São Paulo, Brasil. Foram inscritas 113 TrMT, atribuídas aleatoriamente para uma intervenção com navegadora de pares (75) ou um grupo controle (38) e seguidas durante nove meses. Para analisar a associação entre as variáveis selecionadas e o desfecho ("retenção aos nove meses" independentemente do contato aos três meses, definido pela "resposta completa ao questionário final"), foram empregados modelos de regressão logística bi e multivariados. Uma exploração qualitativa dos formulários de contato de pares foi realizada para validar e complementar a seleção prévia de variáveis do componente quantitativo. Das 113 participantes, 79 (69,9%) responderam à entrevista de nove meses, sendo 54 (72%) do grupo intervenção e 25 (66%) do grupo controle. No modelo multivariado final, o contato aos três meses (odds ratio ajustado - ORa = 6,15; intervalo de 95% de confiança - 95%CI: 2,16-17,51) e a maior escolaridade (≥ 12 anos) (ORa = 3,26; IC95%: 1,02-10,42) permaneceram associados ao desfecho, ajustados por raça/cor, idade < 35 anos e revelação do status sorológico para HIV. Pesquisas futuras com TrMT devem incluir contato em intervalos regulares, com esforços adicionais voltados a participantes com menor escolaridade.

La población de travestis y mujeres trans (TrMT) está en los grupos con mayor prevalencia de VIH en el mundo, con mayor probabilidad de infección en comparación con la población general y menor adherencia a las estrategias de prevención y tratamiento que otros grupos vulnerables. Ante estos desafíos, describimos los factores asociados a la retención de TrMT con VIH en el proyecto TransAmigas. La selección ocurrió entre abril de 2018 y septiembre de 2019, en un servicio público de salud de São Paulo, Brasil. Se inscribieron 113 TrMT, a las cuales se asignaron aleatoriamente a una intervención de navegador de pares (75) o a un grupo control (38) y se les dio seguimiento durante 9 meses. Para analizar la asociación entre las variables seleccionadas y el resultado ("retención a los nueve meses" independientemente del contacto a los 3 meses, definido por "respuesta completa al cuestionario final"), se utilizaron modelos de regresión logística bi- y multivariante. Se realizó una exploración cualitativa de los formularios de contacto de pares para validar y complementar la selección previa de las variables en el componente cuantitativo. De las 113 participantes, 79 (69,9%) respondieron a la entrevista de los 9 meses, de las cuales 54 (72%) pertenecían al grupo intervención y 25 (66%) al grupo control. En el modelo multivariante final, el contacto a los 3 meses (odds ratio ajustado - ORa = 6,15; intervalo de 95% de confianza - IC95%: 2,16-17,51) y un alto nivel de instrucción (≥ 12 años) (ORa = 3,26; IC95%: 1,02-10,42) permanecieron asociados con el resultado, ajustado por etnia/color, edad < 35 años y divulgación del estado serológico respecto al VIH. Los futuros estudios con la población TrMT deberán incluir contacto a intervalos regulares, con esfuerzos adicionales dirigidos a las participantes con menor nivel de instrucción.

Impact of short message service and peer navigation on linkage to care and antiretroviral therapy initiation in South Africa.

OBJECTIVE: We examine the efficacy of short message service (SMS) and SMS with peer navigation (SMS + PN) in improving linkage to HIV care and initiation of antiretroviral therapy (ART). DESIGN: I-Care was a cluster randomized trial conducted in primary care facilities in North West Province, South Africa. The primary study outcome was retention in HIV care; this analysis includes secondary outcomes: linkage to care and ART initiation. METHODS: Eighteen primary care clinics were randomized to automated SMS ( n  = 7), automated and tailored SMS + PN ( n  = 7), or standard of care (SOC; n  = 4). Recently HIV diagnosed adults ( n  = 752) were recruited from October 2014 to April 2015. Those not previously linked to care ( n  = 352) contributed data to this analysis. Data extracted from clinical records were used to assess the days that elapsed between diagnosis and linkage to care and ART initiation. Cox proportional hazards models and generalized estimating equations were employed to compare outcomes between trial arms, overall and stratified by sex and pregnancy status. RESULTS: Overall, SMS ( n  = 132) and SMS + PN ( n  = 133) participants linked at 1.28 [95% confidence interval (CI): 1.01-1.61] and 1.60 (95% CI: 1.29-1.99) times the rate of SOC participants ( n  = 87), respectively. SMS + PN significantly improved time to ART initiation among non-pregnant women (hazards ratio: 1.68; 95% CI: 1.25-2.25) and men (hazards ratio: 1.83; 95% CI: 1.03-3.26) as compared with SOC. CONCLUSION: Results suggest SMS and peer navigation services significantly reduce time to linkage to HIV care in sub-Saharan Africa and that SMS + PN reduced time to ART initiation among men and non-pregnant women. Both should be considered candidates for integration into national programs. TRIAL REGISTRATION: NCT02417233, registered 12 December 2014; closed to accrual 17 April 2015.

Fatores associados à retenção de travestis e mulheres trans vivendo com HIV em uma intervenção com navegação de pares em São Paulo, Brasil / Factores asociados con la retención de travestis y mujeres transgénero que viven con el VIH en una intervención consultada por pares en São Paulo, Brasil / Factors associated with the retention of travestis and transgender women living with HIV in a peer navigation intervention in São Paulo, Brazil

Travestis e mulheres trans (TrMT) pertencem aos grupos com mais alta prevalência do HIV no mundo, com maior probabilidade de infecção em relação à população geral e menor adesão a estratégias de prevenção e tratamento do que outros grupos vulneráveis. Considerando esses desafios, descrevemos os fatores associados à retenção de TrMT com HIV no projeto TransAmigas. O recrutamento ocorreu entre abril de 2018 e setembro de 2019, em um serviço público de saúde em São Paulo, Brasil. Foram inscritas 113 TrMT, atribuídas aleatoriamente para uma intervenção com navegadora de pares (75) ou um grupo controle (38) e seguidas durante nove meses. Para analisar a associação entre as variáveis selecionadas e o desfecho ("retenção aos nove meses" independentemente do contato aos três meses, definido pela "resposta completa ao questionário final"), foram empregados modelos de regressão logística bi e multivariados. Uma exploração qualitativa dos formulários de contato de pares foi realizada para validar e complementar a seleção prévia de variáveis do componente quantitativo. Das 113 participantes, 79 (69,9%) responderam à entrevista de nove meses, sendo 54 (72%) do grupo intervenção e 25 (66%) do grupo controle. No modelo multivariado final, o contato aos três meses (odds ratio ajustado - ORa = 6,15; intervalo de 95% de confiança - 95%CI: 2,16-17,51) e a maior escolaridade (≥ 12 anos) (ORa = 3,26; IC95%: 1,02-10,42) permaneceram associados ao desfecho, ajustados por raça/cor, idade < 35 anos e revelação do status sorológico para HIV. Pesquisas futuras com TrMT devem incluir contato em intervalos regulares, com esforços adicionais voltados a participantes com menor escolaridade.

La población de travestis y mujeres trans (TrMT) está en los grupos con mayor prevalencia de VIH en el mundo, con mayor probabilidad de infección en comparación con la población general y menor adherencia a las estrategias de prevención y tratamiento que otros grupos vulnerables. Ante estos desafíos, describimos los factores asociados a la retención de TrMT con VIH en el proyecto TransAmigas. La selección ocurrió entre abril de 2018 y septiembre de 2019, en un servicio público de salud de São Paulo, Brasil. Se inscribieron 113 TrMT, a las cuales se asignaron aleatoriamente a una intervención de navegador de pares (75) o a un grupo control (38) y se les dio seguimiento durante 9 meses. Para analizar la asociación entre las variables seleccionadas y el resultado ("retención a los nueve meses" independientemente del contacto a los 3 meses, definido por "respuesta completa al cuestionario final"), se utilizaron modelos de regresión logística bi- y multivariante. Se realizó una exploración cualitativa de los formularios de contacto de pares para validar y complementar la selección previa de las variables en el componente cuantitativo. De las 113 participantes, 79 (69,9%) respondieron a la entrevista de los 9 meses, de las cuales 54 (72%) pertenecían al grupo intervención y 25 (66%) al grupo control. En el modelo multivariante final, el contacto a los 3 meses (odds ratio ajustado - ORa = 6,15; intervalo de 95% de confianza - IC95%: 2,16-17,51) y un alto nivel de instrucción (≥ 12 años) (ORa = 3,26; IC95%: 1,02-10,42) permanecieron asociados con el resultado, ajustado por etnia/color, edad < 35 años y divulgación del estado serológico respecto al VIH. Los futuros estudios con la población TrMT deberán incluir contacto a intervalos regulares, con esfuerzos adicionales dirigidos a las participantes con menor nivel de instrucción.

Travestis and transgender women (TrTGW) constitute the groups with the highest HIV prevalence in the world, with higher probability of infection compared with the general population and lower adherence to prevention and treatment strategies than other vulnerable groups. Considering these challenges, this study describes the factors associated with the retention of TrTGW with HIV to the TransAmigas project. Participants were recruited from April 2018 to September 2019 in a public health service in São Paulo, Brazil. A total of 113 TrTGW were randomly assigned to either a peer navigation intervention (75) or a control group (38) and followed up for nine months. To analyze the association between the selected variables and the outcome ("retention at nine months", regardless of contact at three months, defined by the "full completion of the final questionnaire"), bivariate and multivariate logistic regression models were used. Peer contact forms were qualitatively assessed to validate and complement the previous selection of quantitative component variables. Of the 113 participants, 79 (69.9%) participated in the interview after nine months, of which 54 (72%) were from the intervention group and 25 (66%) from the control group. In the final multivariate model, contact at three months (adjusted odds ratio - aOR = 6.15; 95% confidence interval - 95%CI: 2.16-17.51) and higher schooling level (≥ 12 years) (aOR = 3.26; 95%CI: 1.02-10.42) remained associated with the outcome, adjusted by race/skin color, age ≤ 35 years, and HIV serostatus disclosure. Future studies with TrTGW should include contact at regular intervals, with additional efforts aimed at participants with lower schooling level.

Prevalence, motivation, and outcomes of clinic transfer in a clinical cohort of people living with HIV in North West Province, South Africa.

INTRODUCTION: Continuity of care is an attribute of high-quality health systems and a necessary component of chronic disease management. Assessment of health information systems for HIV care in South Africa has identified substantial rates of clinic transfer, much of it undocumented. Understanding the reasons for changing sources of care and the implications for patient outcomes is important in informing policy responses. METHODS: In this secondary analysis of the 2014 - 2016 I-Care trial, we examined self-reported changes in source of HIV care among a cohort of individuals living with HIV and in care in North West Province, South Africa. Individuals were enrolled in the study within 1 year of diagnosis; participants completed surveys at 6 and 12 months including items on sources of care. Clinical data were extracted from records at participants' original clinic for 12 months following enrollment. We assessed frequency and reason for changing clinics and compared the demographics and care outcomes of those changing and not changing source of care. RESULTS: Six hundred seventy-five (89.8%) of 752 study participants completed follow-up surveys with information on sources of HIV care; 101 (15%) reported receiving care at a different facility by month 12 of follow-up. The primary reason for changing was mobility (N=78, 77%). Those who changed clinics were more likely to be young adults, non-citizens, and pregnant at time of diagnosis. Self-reported clinic attendance and ART adherence did not differ based on changing clinics. Those on ART not changing clinics reported 0.66 visits more on average than were documented in clinic records. CONCLUSION: At least 1 in 6 participants in HIV care changed clinics within 2 years of diagnosis, mainly driven by mobility; while most appeared lost to follow-up based on records from the original clinic, self-reported visits and adherence were equivalent to those not changing clinics. Routine clinic visits could incorporate questions about care at other locations as well as potential relocation, particularly for younger, pregnant, and non-citizen patients, to support existing efforts to make HIV care records portable and facilitate continuity of care across clinics. TRIAL REGISTRATION: The original trial was registered with ClinicalTrials.gov , NCT02417233, on 12 December 2014.

Peer Navigation to Support Transgender Women's Engagement in HIV Care: Findings from the Trans Amigas Pilot Trial in São Paulo, Brazil.

Trans women living with HIV (TWH) have suboptimal HIV care engagement. We pilot tested Trans Amigas, a theory-based, trans-specific peer navigation (PN) intervention to address barriers to care in São Paulo, Brazil. TWH were randomized to the PN intervention (n = 75) or control (n = 38) condition. Control participants were referred to trans-friendly HIV care. Intervention participants were assigned a navigator who conducted nine in-person one-on-one sessions and bi-weekly phone or text check-ins to help participants overcome barriers to care and work towards gender affirmation and healthcare goals. We followed participants for 9 months to determine intervention feasibility, acceptability, and preliminary efficacy in improving retention in care. Analyses were intention to treat (ITT). Intervention acceptability was high: at end line, 85.2% of PN participants said they would continue receiving services and 94.4% would recommend peer navigation to a friend. A priori feasibility criteria were met: 92% of eligible participants enrolled and 70% were retained at 9 months; however, only 47% achieved moderate or better adherence to both in-person and phone/text program components. Though the pilot was not powered for efficacy, ITT findings trended toward significance, with intervention participants 40% more likely to be retained in care at the end of the study. Population-specific peer programming to support care engagement is acceptable, feasible, and can improve HIV outcomes for Trans women living with HIV.

RESUMEN: Las mujeres transgénero que viven con VIH (MTV) tienen una participación subóptima en la atención del VIH. Nosotros evaluamos el programa piloto "Trans Amigas", una intervención de navegación (o acompañamiento) de pares (NP) basada en un marco teórico, diseñado específicamente para mujeres transgénero, para abordar las dificultades de acceso a la salud en São Paulo, Brasil. MTV fueron asignadas de manera aleatoria a la intervención (n = 75) o a la condición de control (n = 38). Las participantes del grupo control fueron referidas a una unidad con servicios especializados para MTV. Las participantes en la intervención fueron asignadas a una navegadora, quien realizó nueve sesiones individuales en persona, así como llamadas telefónicas o mensajes de texto cada dos semanas para ayudar a las participantes a superar las barreras de acceso a la atención médica y avanzar hacia sus metas de afirmación de género y de salud. Seguimos a las participantes durante nueve meses para determinar factibilidad, aceptabilidad y eficacia preliminar en la retención en los servicios médicos. Usamos análisis por intención de tratar (AIT). La aceptabilidad de la intervención fue alta: 85.2% de las participantes NP dijeron que les gustaría seguir recibiendo los servicios NP, y 94.4% recomendarían NP a una amiga. El criterio de factibilidad a priori fue alcanzado: 92% de las participantes eligibles se inscribió y el 70% continuó por nueve meses. Sin embargo, solo el 47% alcanzó una adherencia moderada o alta tanto a las visitas en persona como a los mensajes de texto/llamadas telefónicas. Aunque el estudio piloto no tuvo el poder necesario para evaluar eficacia, el AIT reveló una tendencia hacia la significancia de que las participantes de la intervención tuvieran uma retención en la atención médica un 40% mayor. Los programas NP que apoyan el la participación en la atención del VIH, diseñados especificamente para la población, son aceptables, factibles, y pueden mejorar la situación de salud de las mujeres transgénero que viven con VIH.

Impact of SMS and peer navigation on retention in HIV care among adults in South Africa: results of a three-arm cluster randomized controlled trial.

INTRODUCTION: Few interventions have demonstrated improved retention in care for people living with HIV (PLHIV) in sub-Saharan Africa. We tested the efficacy of two personal support interventions - one using text messaging (SMS-only) and the second pairing SMS with peer navigation (SMS+PN) - to improve HIV care retention over one year. METHODS: In a cluster randomized control trial (NCT# 02417233) in North West Province, South Africa, we randomized 17 government clinics to three conditions: SMS-only (6), SMS+PN (7) or standard of care (SOC; 4). Participants at SMS-only clinics received appointment reminders, biweekly healthy living messages and twice monthly SMS check-ins. Participants at SMS+PN clinics received SMS appointment reminders and healthy living messages and spoke at least twice monthly with peer navigators (PLHIV receiving care) to address barriers to care. Outcomes were collected through biweekly clinical record extraction and surveys at baseline, six and 12 months. Retention in HIV care over one year was defined as clinic visits every three months for participants on antiretroviral therapy (ART) and CD4 screening every six months for pre-ART participants. We used generalized estimating equations, adjusting for clustering by clinic, to test for differences across conditions. RESULTS: Between October 2014 and April 2015, we enrolled 752 adult clients recently diagnosed with HIV (SOC: 167; SMS-only: 289; SMS+PN: 296). Individuals in the SMS+PN arm had approximately two more clinic visits over a year than those in other arms (p < 0.01) and were more likely to be retained in care over one year than those in SOC clinics (54% vs. 38%; OR: 1.77, CI: 1.02, 3.10). Differences between SMS+PN and SOC conditions remained significant when restricting analyses to the 628 participants on ART (61% vs. 45% retained; OR: 1.78, CI: 1.08, 2.93). The SMS-only intervention did not improve retention relative to SOC (40% vs. 38%, OR: 1.12, CI: 0.63, 1.98). CONCLUSIONS: A combination of SMS appointment reminders with personalized, peer-delivered support proved effective at enhancing retention in HIV care over one year. While some clients may only require appointment reminders, the SMS+PN approach offers increased flexibility and tailored, one-on-one support for patients struggling with more substantive challenges.

Increases in HIV status disclosure and sexual communication between South African men who have sex with men and their partners following use of HIV self-testing kits.

Availability of HIV self-testing may increase HIV testing frequency among men who have sex with men (MSM). It is unclear, however, if self-testing may impact HIV-related sexual behaviors among MSM, including HIV status disclosure and condom use. We conducted a mixed methods analysis of changes in HIV-related behaviors after HIV self-testing introduction, using data from 110 MSM participating in a feasibility and acceptability study of HIV self-testing in Mpumalanga Province, South Africa. We found increased HIV status disclosure from study participants to sexual partners after HIV self-testing introduction, from 61.8% at baseline to 75.5% at 6-month follow-up (p = 0.04), but decreased condom use with female partners (p = 0.03). Qualitative interviews reveal that some participants used test results to inform condom use. Distribution of self-testing kits can improve mutual disclosure, but should be accompanied by information stressing that the tests may not detect early HIV infections or other sexually transmitted infections.

HIV self-testing among young women in rural South Africa: A randomized controlled trial comparing clinic-based HIV testing to the choice of either clinic testing or HIV self-testing with secondary distribution to peers and partners.

BACKGROUND: HIV testing rates in many hyper-endemic areas are lower than needed to curtail the HIV epidemic. New HIV testing strategies are needed to overcome barriers to traditional clinic based testing; HIV self-testing is one modality that offers promise in reaching individuals who experience barriers to clinic-based testing. METHODS: We conducted a randomized control trial among young women ages 18-26 living in rural Mpumalanga, South Africa where they were randomized in a 1:1 allocation to either the: (1) HIV Counseling and Testing (HCT) arm: an invitation to test at one of the 9 local government clinics where free HCT is provided and is standard of care (SOC), or (2) choice arm: choice of either a clinic-based HCT invitation or oral HIV Self-Testing (HIVST) kits. Depending on the arm, participants were also provided either: (1) 4 HCT invitations to provide to peers/partners for HIV testing at one of the 9 local clinics, or (2) 4 HIV self-test kits to provide to peers/partners (thus 5 total HIVST kits or HCT invitations). Young women were asked to return 3 months and 9 months after enrollment to assess testing uptake and invitation or kit distribution to peers and partners and experiences with testing. Peers and partners who were reported by index participants to have received kits/invitations during follow-up visits were also invited to attend a study visit to assess their testing experiences. The trial is registered at clinical trials.gov NCT03162965. FINDINGS: 287 young women were enrolled and randomized, with 146 randomized to the HCT arm and 141 to the choice (HCT or HIVST) arm. Of those randomized to the choice arm, over 95% (n=135) chose the HIV self-testing kit and only 6 individuals chose HCT. At the 3-month follow-up visit, 92% of index participants in the choice arm reported having tested for HIV compared to 43% of participants in the HCT arm, resulting in a significant risk difference of 49% (95% CI 40%, 58%). By 9 months, this difference decreased to a risk difference of 25% (95% CI 17%, 33%) between arms (96% in the choice arm and 72% in the HCT arm). Participants in the choice arm were also more likely to invite peers and partners to test compared to the HCT arm (94% vs. 76% or an average of 4.97 vs 2.79 tests). Few male partners were invited to test by index participants; however, index participants in the choice arm were more likely to have their male partners test than index participants in the HCT arm (RR 2.99, 95% CI 1.45, 6.16). INTERPRETATION: When given a choice between clinic-based HIV testing and HIV oral self-testing, the overwhelming majority of young women chose HIVST. In addition, those offered a choice of HIV testing modality were much more likely to test, distribute test kits to peers and partners, and to have peers and partners who reported testing compared to the HCT arm. Self-testing offers an important opportunity to significantly increase testing rates among young women and their peers and partners compared to clinic-based HCT. Other strategies to reach men with testing are needed. FUNDING: US National Institutes of Health.

The role of drug resistance in poor viral suppression in rural South Africa: findings from a population-based study.

BACKGROUND: Understanding factors driving virological failure, including the contribution of HIV drug resistance mutations (DRM), is critical to ensuring HIV treatment remains effective. We examine the contribution of drug resistance mutations for low viral suppression in HIV-positive participants in a population-based sero-prevalence survey in rural South Africa. METHODS: We conducted HIV drug resistance genotyping and ART analyte testing on dried blood spots (DBS) from HIV-positive adults participating in a 2014 survey in North West Province. Among those with virologic failure (> 5000 copies/mL), we describe frequency of DRM to protease inhibitors (PI), nucleoside reverse transcriptase inhibitors (NRTI), and non-nucleoside reverse transcriptase inhibitors (NNRTI), report association of resistance with antiretroviral therapy (ART) status, and assess resistance to first and second line therapy. Analyses are weighted to account for sampling design. RESULTS: Overall 170 DBS samples were assayed for viral load and ART analytes; 78.4% of men and 50.0% of women had evidence of virologic failure and were assessed for drug resistance, with successful sequencing of 76/107 samples. We found ≥1 DRM in 22% of participants; 47% were from samples with detectable analyte (efavirenz, nevirapine or lopinavir). Of those with DRM and detectable analyte, 60% showed high-level resistance and reduced predicted virologic response to ≥1 NRTI/NNRTI typically used in first and second-line regimens. CONCLUSIONS: DRM and predicted reduced susceptibility to first and second-line regimens were common among adults with ART exposure in a rural South African population-based sample. Results underscore the importance of ongoing virologic monitoring, regimen optimization and adherence counseling to optimize durable virologic suppression.

HIV self-testing: South African young adults' recommendations for ease of use, test kit contents, accessibility, and supportive resources.

BACKGROUND: The uptake of HIV self-testing (HIVST) could address socio-structural barriers that prevent South African youth from utilizing the testing resources available in their communities. However, to facilitate this, we must tailor components of the HIVST kit and process to ensure that we reach and encourage youth to test. The purpose of this study to elucidate concerns and issues regarding HIVST rollout among South African youth. METHODS: This study was conducted in two phases: 1) focus group discussions with rural, South African youth aged 18-24 and 2) direct observations of participants completing with an oral HIVST kit and/or a blood based HIVST kit. In phase 2a participants were invited to try both an oral and blood-based HIVST kit. In phase 2b, participants selected the HIVST kit of their choice. RESULTS: We enrolled 35 unique participants in phase 1, 20 participants in phase 2a, and 40 participants in phase 2b. While the focus group discussions highlighted hypothetical HIVST use only, participants appreciated the privacy that the HIVST could afford them. However, they expressed concerns about whether HIVST could be trusted due to false positives and negatives, as well as whether a person would be able to emotionally handle the results if they tested alone. They suggested that the kits be used alongside someone who could provide support. In phases 2a and 2b, participants were overwhelmingly positive about both kits regarding ease of use and whether their results could be trusted. The participants, however, experienced more challenges with the blood-based versus oral test. When given the choice in phase 2b, most participants (80%) chose the oral HIVST over the blood-based HIVST. CONCLUSIONS: During the focus group discussions, participants raised concerns about the validity of HIVST, lack of emotional support when testing alone, and the cost of HIVST kits, all of which could be addressed through current testing campaigns. Most of those who actually tested had positive experiences with HIVST and would recommend it to their friends. When offered a choice, most preferred the oral test. TRIAL REGISTRATION: NCT03162965 , registered 19th May 2017.

Ability to use oral fluid and fingerstick HIV self-testing (HIVST) among South African MSM.

BACKGROUND: HIV self-testing (HIVST) may increase HIV testing uptake, facilitating earlier treatment for key populations like MSM who experience barriers accessing clinic-based HIV testing. HIVST usability among African MSM has not been explored. METHODS: We assessed usability of oral fluid (OF) and fingerstick (FS; blood) HIVST kits during three phases among MSM with differing degrees of HIVST familiarity in Mpumalanga, South Africa. In 2015, 24 HIVST-naïve MSM conducted counselor-observed OF and FS HIVST after brief demonstration. In 2016 and 2017, 45 and 64 MSM with experience using HIVST in a pilot study chose one HIVST to conduct with a counselor-observer present. In addition to written, the latter group had access to video instructions. We assessed frequency of user errors and reported test use ease, changes in error frequency by phase, and covariates associated with correct usage using log-Poisson and Gaussian generalized estimating equations. RESULTS: Among OF users (n = 57), 15-30% committed errors in each phase; however, observers consistently rated participants as able to test alone. Among FS users (n = 100), observers noted frequent errors, most commonly related to blood collection and delivery. We found suggestive evidence (not reaching statistical significance) that user errors decreased, with 37.5%, to 28.1%, and 18.2% committing errors in phases I, II, and III, respectively (p-value:0.08), however observer concerns remained constant. Ease and confidence using HIVST increased with HIV testing experience. Participants using three HIVST were more likely (RR:1.92, 95% CI:1.32, 2.80) to report ease compared to those without prior HIVST experience. Never testers (RR:0.66, 95% CI:0.44-0.99) reported less ease performing HIVST compared to participants testing in the past six months. CONCLUSIONS: MSM were able to perform the OF test. Fingerstick test performance was less consistent; however preference for fingerstick was strong and performance may improve with exposure and instructional resources. Continued efforts to provide accessible instructions are paramount.

Beyond Social Desirability Bias: Investigating Inconsistencies in Self-Reported HIV Testing and Treatment Behaviors Among HIV-Positive Adults in North West Province, South Africa.

This mixed-methods study used qualitative interviews to explore discrepancies between self-reported HIV care and treatment-related behaviors and the presence of antiretroviral medications (ARVs) in a population-based survey in South Africa. ARV analytes were identified among 18% of those reporting HIV-negative status and 18% of those reporting not being on ART. Among participants reporting diagnosis over a year prior, 19% reported multiple HIV tests in the past year. Qualitative results indicated that participant misunderstandings about their care and treatment played a substantial role in reporting inaccuracies. Participants conflated the term HIV test with CD4 and viral load testing, and confusion with terminology was compounded by recall difficulties. Data entry errors likely also played a role. Frequent discrepancies between biomarkers and self-reported data were more likely due to poor understanding of care and treatment and biomedical terminology than intentional misreporting. Results indicate a need for improving patient-provider communication, in addition to incorporating objective measures of treatment and care behaviors such as ARV analytes, to reduce inaccuracies.

A Mobile Health Strategy to Support Adherence to Antiretroviral Preexposure Prophylaxis.

Preexposure prophylaxis is a highly protective HIV prevention strategy, yet nonadherence can significantly reduce its effectiveness. We conducted a mixed methods evaluation of a mobile health intervention (iText) that utilized weekly bidirectional text or e-mail support messages to encourage preexposure prophylaxis (PrEP) adherence among participants in the multi-site iPrEx open-label extension study. A convenience sample of PrEP users from the San Francisco and Chicago sites participated in a 12-week pilot study. Fifty-six men who have sex with men were enrolled; a quarter of them were less than 30 years of age, 13% were black/African American, 11% were Latino, and most (88%) completed some college. Two-thirds opted for text message delivery. Of the 667 messages sent, only 1 individual requested support; initial nonresponse was observed in 22% and was higher among e-mail compared to text message recipients. Poststudy, a majority of participants would recommend the intervention to others, especially during PrEP initiation. Moreover, younger participants and men of color were more likely to report that they would use the iText strategy if it were available to them. Several participants commented that while they were aware that the messages were automated, they felt supported and encouraged that "someone was always there." Study staff reported that the intervention is feasible to administer and can be incorporated readily into clinic flow. A pre-post intervention regression discontinuity analysis using clinic-based pill counts showed a 50% reduction in missed doses [95% confidence interval (CI) 16-71; p = 0.008] and 77% (95% CI 33-92; p = 0.007) when comparing pill counts at quarterly visits just before and after iText enrollment. A mobile health intervention using weekly bidirectional messaging was highly acceptable and demonstrated promising effects on PrEP adherence warranting further evaluation for efficacy in a randomized controlled trial.

High Acceptability and Increased HIV-Testing Frequency After Introduction of HIV Self-Testing and Network Distribution Among South African MSM.

BACKGROUND: South African men who have sex with men (MSM) have a high burden of undiagnosed HIV infection and HIV-testing rates incommensurate with their risk. HIV self-testing (HIVST) may increase testing uptake, frequency, and earlier HIV detection and treatment. SETTING: Gert Sibande and Ehlanzeni districts, Mpumalanga Province, South Africa. METHODS: We conducted a longitudinal HIVST study among MSM between June 2015 and May 2017. Overall 127 HIV-negative MSM were provided with up to 9 test kits of their choice-oral fluid or blood fingerstick-to use themselves and distribute to their networks. Surveys conducted 3- and 6-month post-enrollment elicited information on HIVST experiences, preferences, acceptability, utilization, and distribution. We used generalized estimating equations to assess changes in testing frequency. RESULTS: Ninety-one percent of participants self-tested. All participants who self-tested reported being likely to self-test again, with over 80% preferring HIVST to clinic-based testing. Fingerstick was preferred to oral fluid tests by approximately 2:1. Returning participants distributed 728 tests to sexual partners (18.5% of kits), friends (51.6%), and family (29.8%). Six participants seroconverted during the study, and 40 new diagnoses were reported among test recipients. Frequent (semi-annual) testing increased from 37.8% before the study to 84.5% at follow-up (P < 0.001), and participants reported anticipated frequent testing of 100% if HIVST were available compared with 84% if only clinic-testing were available in the coming year (P < 0.01). CONCLUSIONS: HIVST use and network distribution is acceptable and feasible for MSM in South Africa and can increase testing uptake and frequency, potentially improving early detection among MSM and their networks.

Risk, safety and sex among male PrEP users: time for a new understanding.

Recent advances in biomedical HIV prevention have led to optimistic projections of a dramatic worldwide reduction of new infections by 2030. This optimism is counterbalanced by concerns that the protective benefits of one such technology, HIV pre-exposure prophylaxis (PrEP), may be negated by increases in other behaviours that offset these benefits (risk compensation). To contribute to a deeper understanding of concepts of safety and risk in the context of HIV PrEP, we draw on the narrative accounts of 61 male PrEP users who participated in the inaugural PrEP demonstration project: the iPrEx open-label extension study. We conducted in-depth interviews with a purposeful sample of iPrEx participants. Overall, participants did not report significant changes to their sexual practices once they had begun taking PrEP. Rather, participants reported experiencing a sense of relief or reprieve from HIV-related stress. This unburdening of fear did not necessarily lead to condomless sex. Instead, men expressed feeling a sense of security and less free-floating fear of HIV. We contend that no longer living under the threat of HIV is a significant benefit that has not been adequately explored in HIV prevention research.

Evaluation of short message service and peer navigation to improve engagement in HIV care in South Africa: study protocol for a three-arm cluster randomized controlled trial.

BACKGROUND: In countries with a high burden of HIV, such as South Africa, where the epidemic remains the world's largest, improving early uptake of and consistent adherence to antiretroviral therapy could bring substantial HIV prevention gains. However, patients are not linked to or retained in care at rates needed to curtail the epidemic. Two strategies that have demonstrated a potential to stem losses along the HIV care cascade in the sub-Saharan African context are use of text messaging or short message service (SMS) and peer-navigation services. METHODS/DESIGN: We designed a cluster randomized trial to assess the efficacy of an SMS intervention and a peer-navigation intervention to improve retention in care and treatment, timely linkage to care and treatment, medication adherence, and prevention behaviors in South Africa. Eighteen primary and community healthcare clinics in Rustenburg and Moses Kotane Sub-districts in the North West Province were randomized to one of three conditions: SMS intervention (n = 7), peer navigation intervention (n = 7), or standard of care (n = 4). Approximately 42 participants are being recruited at each clinic, which will result in a target of 750 participants. Eligible participants include patients accessing HIV testing or care in a study clinic, recently diagnosed with HIV, aged 18 years or older, and with access to a cellular telephone where they are willing to receive automated SMS with HIV-related messaging. Data collection includes extraction of visit information from clinical files and participant surveys at baseline, 6 months, and 12 months. Intent-to-treat (ITT) analysis will explore differences between randomization arms and the primary outcome of patient retention in care at 12 months following enrollment. We will also explore secondary outcomes including participants' a) timely linkage to care (within 3 months of HIV diagnosis), b) adherence to treatment based on self-report and clinic's medication dispensation dates, and c) condom-use behaviors. DISCUSSION: The findings will allow us to compare the efficacy of two complementary interventions, one that requires fewer resources to implement (SMS) and one (peer navigation) that offers more flexibility in terms of the patient barriers to care that it can address. TRIAL REGISTRATION: NCT02417233, registered 12 December 2014.

Participant experiences and facilitators and barriers to pill use among men who have sex with men in the iPrEx pre-exposure prophylaxis trial in San Francisco.

In 2010, the iPrEx study demonstrated efficacy of daily emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) pre-exposure prophylaxis (PrEP) in reducing HIV acquisition among men who have sex with men. Adherence to study product was critical for PrEP efficacy, and varied considerably, with FTC/TDF detection rates highest in the United States. We conducted a qualitative study to gain insights into the experiences of iPrEx participants in San Francisco (SF) where there was high confirmed adherence, to understand individual and contextual factors influencing study product use in this community. In 2009 and 2011, we conducted focus groups and in-depth interviews in 36 and 16 SF iPrEx participants, respectively. Qualitative analyses indicate that participants joined the study out of altruism. They had a clear understanding of study product use, and pill taking was facilitated by establishing or building on an existing routine. Participants valued healthcare provided by the study and relationships with staff, whom they perceived as nonjudgmental, and found client-centered counseling to be an important part of the PrEP package. This facilitated pill taking and accurate reporting of missed doses. Adherence barriers included changes in routine, side effects/intercurrent illnesses, and stress. Future PrEP adherence interventions should leverage existing routines and establish client-centered relationships/ environments to support pill taking and promote accurate reporting.