First case report of a perinatally HIV-infected infant with HIV resistance to dolutegravir associated with tenofovir/lamivudine/dolutegravir use in mothers.

Perinatally HIV-infected infants can be infected with a drug-resistant virus or select for drug resistance by exposure to sub-therapeutic levels of maternal antiretroviral drugs present in breastmilk or from sub-therapeutic infant prophylaxis. We report a case of dolutegravir resistance detected in a treatment-naive perinatally HIV-infected infant whose mother was receiving tenofovir/lamivudine/dolutegravir. This case was detected during a national survey of HIV drug resistance in Haiti amongst infants testing positive for HIV through the national early infant diagnosis program between April 2020 and March 2021. This unique case underscores the need for prompt management of high viral loads in pregnant and breastfeeding women and supports HIV drug resistance surveillance efforts targeted at antiretroviral therapy-naive infants born to mothers in low-and middle-income countries.

A sub-group evaluation of the multi-month dispensing strategy for differentiated HIV care: is personalization of care guidelines warranted in Haiti?

BACKGROUND: Differentiated care strategies are rapidly becoming the norm for HIV care delivery globally. Building upon an interest in tailoring antiretroviral therapy (ART) delivery for client-centered needs, the Ministry of Health and Population in Haiti formally endorsed multiple-month dispenses (MMD) in the 2016 national ART guidelines This study explores heterogeneity in retention in care with MMD for specific Haitian populations living with HIV and evaluates if a targeted algorithm for optimal ART prescription intervals is warranted in Haiti. METHODS: This study included ART-naïve individuals who started ART on or after January 1st, 2017 in Haiti. To identify subgroups in which to explore heterogeneity of retention, we implemented a double-lasso regression method to determine which individual characteristics would define the subgroups. Characteristics evaluated for potential subgroup definition included: sex, age category, WHO clinical stage, and body mass index category. We employed instrumental variable models to estimate the causal effect of increasing ART dispensing length on ART retention, by client subgroup. The outcome of interest was retention in care after one year in treatment. We then estimated the marginal effect of a 30-day increase to ART dispensing length to retention in care for each of these subgroups. RESULTS: There was evidence for heterogeneity in the effect of extending ART dispensing intervals on retention by WHO clinical stage. We observed significant improvements to retention in care at one year with a 30-day increase in ART dispense length for all subgroups defined by WHO clinical stages 1-4. The effects ranged from a 14.7% increase (95% CI: 12.4-17.0) to the likelihood of retention for people with HIV in WHO stage 1 to a 21.6% increase (95% CI: 18.7-24.5) to the likelihood of retention for those in WHO stage 3. CONCLUSIONS: All the subgroups defined by WHO clinical stage experienced a benefit of extending ART intervals to retention in care at one year. Though the effect did differ slightly by WHO stage, the effects went in the same direction and were of similar magnitude. Therefore, a standardized recommendation for MMD among those living with HIV and new on ART is appropriate for Haiti treatment guidelines.

Timely initiation of HIV antiretroviral therapy in Haiti 2004-2018: a retrospective cohort study.

OBJECTIVE: To describe trends in timing of ART initiation for newly diagnosed people living with HIV before and after Haiti adopted its Test and Start policy for universal HIV antiretroviral therapy (ART) in July 2016, and to explore predictors of timely ART initiation for both newly and previously diagnosed people living with HIV following Test and Start adoption. METHODS: This retrospective cohort study explored timing of ART initiation among 147 900 patients diagnosed with HIV at 94 ART clinics in 2004-2018 using secondary electronic medical record data. The study used survival analysis methods to assess time trends and risk factors for ART initiation. RESULTS: Timely uptake of ART expanded with Test and Start, such that same-day ART initiation rates increased from 3.7% to 45.0%. However, only 11.0% of previously diagnosed patients initiated ART after Test and Start. In adjusted analyses among newly diagnosed people living with HIV, factors negatively associated with timely ART initiation included being a pediatric patient aged 0-14 years (HR = 0.23, p < 0.001), being male (HR = 0.92, p = 0.03), being 50+ years (HR = 0.87, p = 0.03), being underweight (HR = 0.79, p < 0.001), and having WHO stage 3 (HR = 0.73, p < 0.001) or stage 4 disease (HR = 0.49, p < 0.001). Variation in timely ART initiation by geographic department and health facility was observed. CONCLUSIONS: Haiti has made substantial progress in scaling up Test and Start, but further work is needed to enroll previously diagnosed patients and to ensure rapid ART in key patient subgroups. Further research is needed on facility and geographic factors and on strategies for improving timely ART initiation among vulnerable subgroups.

Timely initiation of HIV antiretroviral therapy in Haiti 2004–2018: a retrospective cohort study

[ABSTRACT]. Objective. To describe trends in timing of ART initiation for newly diagnosed people living with HIV before and after Haiti adopted its Test and Start policy for universal HIV antiretroviral therapy (ART) in July 2016, and to explore predictors of timely ART initiation for both newly and previously diagnosed people living with HIV following Test and Start adoption. Methods. This retrospective cohort study explored timing of ART initiation among 147 900 patients diagnosed with HIV at 94 ART clinics in 2004–2018 using secondary electronic medical record data. The study used survival analysis methods to assess time trends and risk factors for ART initiation. Results. Timely uptake of ART expanded with Test and Start, such that same-day ART initiation rates increased from 3.7% to 45.0%. However, only 11.0% of previously diagnosed patients initiated ART after Test and Start. In adjusted analyses among newly diagnosed people living with HIV, factors negatively associated with timely ART initiation included being a pediatric patient aged 0–14 years (HR = 0.23, p < 0.001), being male (HR = 0.92, p = 0.03), being 50+ years (HR = 0.87, p = 0.03), being underweight (HR = 0.79, p < 0.001), and having WHO stage 3 (HR = 0.73, p < 0.001) or stage 4 disease (HR = 0.49, p < 0.001). Variation in timely ART initiation by geographic department and health facility was observed. Conclusions. Haiti has made substantial progress in scaling up Test and Start, but further work is needed to enroll previously diagnosed patients and to ensure rapid ART in key patient subgroups. Further research is needed on facility and geographic factors and on strategies for improving timely ART initiation among vulnerable subgroups.

[RESUMO]. Objetivo. Descrever as tendências para o momento do início da terapia antirretroviral (TAR) em pessoas recém diagnosticadas vivendo com HIV antes de e após o Haiti adotar a política Testar e Tratar com a TAR universal para HIV, em julho de 2016, e analisar os preditores do início precoce da TAR em pessoas recém ou previamente diagnosticadas que vivem com HIV após a adoção da política Testar e Tratar. Métodos. Este estudo de coorte retrospectivo analisou o momento do início da TAR de 147 900 pacientes diagnosticados com HIV em 94 ambulatórios de TAR entre 2004 e 2018, usando dados de registros médicos eletrônicos secundários. O estudo usou métodos de análise de sobrevivência para avaliar as tendências temporais e os fatores de risco para o início da TAR. Resultados. A adoção precoce da TAR foi ampliada com a política Testar e Tratar de tal maneira que as taxas do início da TAR no mesmo dia do diagnóstico aumentaram de 3,7% para 45%. Porém, somente 11% dos pacientes previamente diagnosticados iniciaram a TAR após a política Testar e Tratar. Nas análises ajustadas entre as pessoas recém diagnosticadas vivendo com HIV, os fatores negativamente associados ao início precoce da TAR incluíram: ser paciente pediátrico de 0 a 14 anos de idade (HR = 0,23, p < 0,001), ser do sexo masculino (HR = 0,92, p = 0,03), ter 50 anos de idade ou mais (HR = 0,87, p = 0,03), ter peso inferior ao normal (HR = 0,79, p < 0.001) e estar na fase 3 da OMS (HR = 0,73, p < 0,001) ou fase 4 da doença (HR = 0,49, p < 0,001). Foi observada variação no início precoce da TAR por região geográfica e instituição de saúde. Conclusões. O Haiti obteve avanços substanciais na ampliação da política Testar e Tratar, mas é necessário mais trabalho para inscrever pacientes previamente diagnosticados e para assegurar a TAR rápida em subgrupos-chave de pacientes. Mais pesquisas são necessárias sobre fatores geográficos e de instituições de saúde e sobre estratégias para a melhoria do início precoce da TAR entre subgrupos vulneráveis.

[RESUMEN]. Objetivo. Describir las tendencias en cuanto al momento de iniciar el tratamiento antirretroviral (TAR) de personas con infección por el VIH recién diagnosticadas antes y después de julio del 2016, cuando Haití adoptó la política de prueba e inicio del tratamiento con el TAR universal contra el VIH, y explorar los factores predictivos del inicio oportuno del TAR en personas con infección por el VIH recién diagnosticada y diagnosticada con anterioridad después de la adopción de esta política. Métodos. En este estudio de cohortes retrospectivo se exploró el momento en que se inició el TAR en 147 900 pacientes con diagnóstico de infección por el VIH en 94 consultorios que administran TAR del 2004 al 2018 mediante datos secundarios de expedientes médicos electrónicos. El estudio empleó métodos de análisis de supervivencia para evaluar las tendencias temporales y los factores de riesgo del inicio del TAR. Resultados. La observancia oportuna del TAR se amplió con la política de prueba e inicio del tratamiento, de tal manera que el inicio del TAR en el mismo día aumentó de 3,7 % a 45,0 %. Sin embargo, solo 11,0 % de los pacientes anteriormente diagnosticados iniciaron el TAR tras la adopción de la política. En los análisis ajustados con personas con infección por el VIH recién diagnosticadas, los factores asociados negativamente con el inicio oportuno del TAR comprendían ser un paciente pediátrico entre 0 y 14 años de edad (HR = 0,23, p < 0,001), ser varón (HR = 0,92, p = 0,03), tener más de 50 años (HR = 0,87, p = 0,03), tener un peso bajo (HR = 0,79,p < 0.001) y estar en el estadio 3 (de HR = 0,73, p < 0,001) o en estadio 4 (HR = 0,49, p < 0,001) de la enfermedad según la OMS. Se consideró la variación en el inicio oportuno del TAR según departamento geográfico y establecimiento de salud. Conclusiones. Haití ha logrado avances considerables en la ampliación a mayor escala de la política de prueba e inicio del tratamiento, pero es necesario seguir trabajando para registrar a los pacientes diagnosticados con anterioridad y para asegurar el inicio rápido del TAR en los subgrupos de pacientes clave. Es preciso llevar a cabo investigaciones adicionales sobre los factores geográficos y los relacionados con los establecimientos y sobre las estrategias para mejorar el inicio oportuno del TAR en los subgrupos vulnerables.

Estimating the effect of increasing dispensing intervals on retention in care for people with HIV in Haiti.

BACKGROUND: Multi-month dispensing (MMD) for antiretroviral therapy (ART) is a promising care strategy to improve HIV treatment adherence. The effectiveness of MMD in routine settings has not yet been evaluated within a causal inference framework. We analyzed data from a robust clinical data system to evaluate MMD in Haiti. METHODS: We assessed 1-year retention in care among 21,880 ART-naïve HIV-positive persons who started ART on or after January 1, 2017, up until November 1, 2018. We used an instrumental variable analysis to estimate the causal impact of MMD. This approach was used to address potential selection into specific dispensing intervals because MMD is not randomly applied to individuals. FINDINGS: We found that extending ART dispensing intervals increased the probability of retention at 12 months after ART initiation, with up to a 24·2%-point increase (95%CI: 21·9, 26·5) in the likelihood of retention with extending dispenses by 30 days for those receiving one-month dispenses. We observed statistically significant gains to retention with MMD with up to an approximately 4-month supply of ART; +5·1%-points (95%CI: 2·4,7·8). Increasing dispensing lengths for those already receiving ≥5-month supply of ART had a potentially negative effect on retention. INTERPRETATION: MMD for ART is an effective service delivery strategy that improves care retention for new ART recipients. There is a potentially negative effect of increasing prescription lengths for those new ART recipients already receiving longer ART supplies, though more research is needed to characterize this effect given medication supplies of this length are not common for newer ART recipients.

Importance of support groups to the health and well-being of vulnerable children and young people living with HIV: a case study of the Kids Clubs program in Haiti.

BACKGROUND: Although access to antiretroviral therapy (ART) among children and young people living with HIV has increased in recent years, adherence to medication and viral suppression remain challenges. Evidence of benefits of support groups is growing and reflects a range of models and approaches. Since 2014, hospital-linked psychosocial support groups for children and young people living with HIV, known as Kids Clubs, have been established throughout Haiti. The program provides safe spaces for them to meet with peers, supports medication adherence, delivers health and life skills education, and facilitates linkages with clinic visits and social services. This study describes program enrollment and participant engagement, ART adherence and viral suppression among participants, and other outcomes attributed to the program by participants, caregivers, and program implementers. METHODS: Our mixed methods study included quantitative analysis of program monitoring data on rollout and attendance, and medication adherence and viral load results extracted from medical records. We collected qualitative data from club members, caregivers, and implementers about their experiences with the clubs and the impact of participation. RESULTS: From January 2014-December 2018, 1330 individuals aged 8-29 were enrolled in the program; over three-quarters participated for at least 12 months. In 2018, 1038 members attended at least one club meeting; more than half missed three or fewer monthly meetings. Three-quarters of ever-enrolled members reported consistent medication use at their most recent clinic visit; 64.2% (600/935) of those with a recent viral load test were virally suppressed. Level of club attendance was positively associated with ART adherence (p < 0.01) and viral suppression (p < 0.05). Club members, caregivers, and implementers noted the value of the clubs to participants' retention in care and medication adherence, health knowledge, and capacity to deal with peer pressure, stigma, shyness, and depression. CONCLUSIONS: The Kids Club program has been successful in scaling HIV support services to highly vulnerable children and young people through peer-based groups, and program participation has led to a range of benefits. Efforts to innovate, evaluate, and scale support strategies for vulnerable young populations must be accelerated in order to ensure that they survive, thrive, and reach their full potential.

Short-Term Effects of the COVID-19 Pandemic on HIV Care Utilization, Service Delivery, and Continuity of HIV Antiretroviral Treatment (ART) in Haiti.

INTRODUCTION: Our study describes changes in HIV care service delivery and continuity of HIV antiretroviral therapy (ART) for people living with HIV (PLHIV) during the 8 weeks before and after diagnosis of the first coronavirus disease 2019 (COVID-19) cases in Haiti on March 19, 2020. METHODS: Using data from 96 out of 167 health facilities offering ART services, we compared four ART program indicators: (1) count of HIV visits; (2) proportion of ART dispenses in community-based settings (DAC); (3) proportion of multi-month dispensing of ART medications > 6 months (> 6 m MMD); and (4) proportion of timely ART refills. We used uncontrolled interrupted time series (ITS) models to estimate slope and level changes in each indicator with the arrival of COVID-19. RESULTS AND DISCUSSION: From week 1 to week 16, the average number of HIV visits fell from 121.5 to 92.5 visits, the proportion of DAC rose from 22.7% to 36.7%, the proportion of > 6 m MMD rose from 29.4% to 48.4%, and the proportion of timely ART refills fell from 51.9% to 43.8%. The ITS models estimated abrupt increases of 36% in > 6 m MMD (p < 0.001) and 37% in DAC (p < 0.001) at the time of COVID-19 arrival, and no change after arrival of COVID-19. The was an abrupt decline of 18% in timely ART refills with the arrival of COVID-19 and a decline of 1% per week thereafter, both non-statistically significant changes. CONCLUSIONS: The sudden changes in HIV service utilization represent dramatic adaptations needed to mitigate primary and secondary effects of the COVID-19 pandemic on PLHIV. This study underscores the urgency of optimizing ART delivery models in Haiti and beyond, in order to maintain progress toward HIV epidemic control.

Risk factors for delayed viral suppression on first-line antiretroviral therapy among persons living with HIV in Haiti, 2013-2017.

Studies of viral suppression on first-line antiretroviral therapy (ART) in persons living with human immunodeficiency virus (PLHIV) in Haiti are limited, particularly among PLHIV outside of the Ouest department, where the capital Port-au-Prince is located. This study described the prevalence and risk factors for delayed viral suppression among PLHIV in all geographic departments of Haiti between 2013 and 2017. Individuals who received viral load testing 3 to 12 months after ART initiation were included. Data on demographics and clinical care were obtained from the Haitian Active Longitudinal Tracking of HIV database. Multivariable logistic regression was performed to predict delayed viral suppression, defined as a viral load ≥1000 HIV-1 RNA copies/mL after at least 3 months on ART. Viral load test results were available for 3,368 PLHIV newly-initiated on ART. Prevalence of delayed viral suppression was 40%, which is slightly higher than previous estimates in Haiti. In the multivariable analysis, delayed viral suppression was significantly associated with younger age, receiving of care in the Ouest department, treatment with lamivudine (3TC), zidovudine (AZT), and nevirapine (NVP) combined ART regimen, and CD4 counts below 200 cells/mm3. In conclusion, this study was the first to describe and compare differences in delayed viral suppression among PLHIV by geographic department in Haiti. We identified populations to whom public health interventions, such as more frequent viral load testing, drug resistance testing, and ART adherence counseling should be targeted.

An EMR-Based Alert with Brief Provider-Led ART Adherence Counseling: Promising Results of the InfoPlus Adherence Pilot Study Among Haitian Adults with HIV Initiating ART.

To promote HIV antiretroviral therapy (ART) outcomes in Haiti, we developed a culturally relevant intervention (InfoPlus Adherence) that combines an electronic medical record alert identifying patients at elevated risk of treatment failure and provider-delivered brief problem-solving counseling. We conducted a quasi-experimental mixed-methods study among 146 patients at two large ART clinics in Haiti with 728 historical controls. We conducted quantitative assessments of patients at baseline and intervention completion (6 months) as well as focus groups with health workers and exit interviews with patients. The primary quantitative outcome measures were HIV viral suppression according to medical record and ART adherence in terms of ≥ 90% for "proportion of days covered" (PDC) according to pharmacy dispensing data. Results indicated that the proportion of intervention patients with suppressed VL during the study/historical periods was 80.0%/86.0% and 76.8%/87.4% for controls. In a difference-in-differences (DID) analytic model, the adjusted relative risk for viral suppression with the intervention was 1.15 (95% CI 0.92-1.45, p = 0.21), representing favorable but non-significant association between the intervention and the trajectory of VL outcomes. PDC ≥ 90% during the study/historical periods was 30.9%/11.0% among intervention participants and 16.9%/19.4% among controls. In the adjusted DID model, the relative risk for of PDC ≥ 90% with the intervention was 4.00 (95% CI 1.91-8.38, p < 0.001), representing a highly favorable association between the intervention and the trajectory of PDC outcomes. Qualitative data affirmed acceptability of the intervention, although providers reported some challenges consistently implementing it. Future research is needed to demonstrate efficacy and explore optimal implementation strategies.

Local and national stakeholders' perceptions towards implementing and scaling up HIV self-testing and secondary distribution of HIV self-testing by Option B+ patients as an assisted partner service strategy to reach men in Haiti.

HIV self-testing (HIVST), which allows people to test in private, is an innovative testing strategy that has been shown to increase HIV testing among men. Delivering HIVST kits to men via women is one promising assisted partner service strategy. Little research has been conducted on HIVST secondary distribution to men by women living with HIV (WLWH) in the Caribbean and other settings. The purpose of this study was to assess the perspectives of WLWH, their male partners, and healthcare professionals on the perceived advantages and disadvantages of HIVST, and recommendations for implementing HIVST in Haiti, with a focus on secondary distribution of HIVST to men by WLWH. Sixteen key informant interviews and nine focus groups with 44 healthcare workers, 31 Option B+ clients, and 13 men were carried out in Haiti. Key informants were representatives of the Ministry of Health and of a non-governmental agency involved in HIV partner services. Focus group members included program leads and staff members from the HIV care and treatment program, the Option B+ program, the community health service program, and the HIV counseling and testing services from 2 hospitals. Perceived HIVST advantage included an increase in the number of people who would learn their HIV status and start treatment. The perceived disadvantages were lack of support to ensure self-testers initiate treatment, uncertainty about male partner's reaction, risk of violence towards women delivering HIVST kits after receiving an HIVST kit from a woman, and the inability of women to counsel a man in case his self-test result is positive. Recommendations for integrating HIVST and secondary distribution of HIVST by WLWH included coupling HIVST distribution with public information, education, and communication through media and social marketing, relying on community health workers to mediate use of HIVST and ensure linkage to care, piloting HIVST programs on a small scale. HIVST is an appropriate and feasible strategy HIV prevention for men and women; however, more research is needed on how best to implement different strategies for this approach in the Caribbean.

Expanded access to viral load testing and use of second line regimens in Haiti: time trends from 2010-2017.

BACKGROUND: Haiti initiated the scale-up of HIV viral load (VL) testing in 2015-2016, with plans to achieve 100% coverage for all patients on antiretroviral therapy (ART) for treatment of HIV/AIDS. In the absence of HIV drug susceptibility testing, VL testing is a key tool for monitoring response to ART and optimizing treatment results. This study describes trends in expanded use of VL testing, VL results, and use of second-line ART regimens, and explores the association between VL testing and second-line regimen switching in Haiti from 2010 to 2017. METHODS: We conducted a retrospective cohort study with 66,042 patients drawn from 88 of Haiti's 160 national ART clinics. Longitudinal data from the iSanté electronic data system was used to analyze the trends of interest. We described patients' VL testing status in five categories based on up to two most recent VL test results: no test; suppressed; unsuppressed followed by no test; re-suppressed; and confirmed failure. Among those with confirmed failure, we described ART adherence level. Finally, we used Cox proportional hazards regression to estimate the risk of second-line regimen switching by VL testing status, after adjusting for other individual characteristics. RESULTS: The number of patients who had tests done increased annually from 11 in 2010 to 18,828 in the first 9 months of 2017, while the number of second-line regimen switches rose from 21 to 279 during this same period. Compared with patients with no VL test, the hazard ratio (HR) for switching to a second-line regimen was 22.2 for patients with confirmed VL failure (95% confidence interval [CI] for HR: 18.8-26.3; p < 0.005) after adjustment for individual characteristics. Among patients with confirmed VL failure, 44.7% had strong adherence, and fewer than 20% of patients switched to a second-line regimen within 365 days of VL failure. CONCLUSIONS: Haiti has significantly expanded access to VL testing since 2016. In order to promote optimal patient health outcomes, it is essential for Haiti to continue broadening access to confirmatory VL testing, to expand evidence-based initiatives to promote strong ART adherence, and to embrace timely switching for patients with confirmed ART failure despite strong ART adherence.

Toward Universal HIV Treatment in Haiti: Time Trends in ART Retention After Expanded ART Eligibility in a National Cohort From 2011 to 2017.

BACKGROUND: The World Health Organization (WHO) recommends universal antiretroviral therapy (ART) for persons living with HIV (PLWH), but evidence about effects of expanded ART access on ART retention in low-resource settings is limited. SETTING: Haiti's Ministry of Health endorsed universal ART for pregnant women in March 2013 (Option B+) and for all PLWH in July 2016. This study included 51,579 ART patients from 2011 to 2017 at 94 hospitals and clinics in Haiti. METHODS: This observational, retrospective cohort study described time trends in 6-month ART retention using secondary data, and compared results during 3 periods using an interrupted time series model: pre-Option B+ (period 1: 1/11-2/13), Option B+ (period 2: 3/13-6/16), and Test and Start (T&S, period 3: 7/16-9/17). RESULTS: From the pre-Option B+ to the T&S period, the monthly count of new ART patients increased from 366/month to 877/month, and the proportion with same-day ART increased from 6.3% to 42.1% (P < 0.001). The proportion retained on ART after 6 months declined from 78.4% to 75.0% (P < 0.001). In the interrupted time series model, ART retention improved by a rate of 1.4% per quarter during the T&S period after adjusting for patient characteristics (adjusted incidence rate ratio = 1.014; 95% confidence interval: 1.002 to 1.026, P < 0.001). However, patients with same-day ART were 14% less likely to be retained compared to those starting ART >30 days after HIV diagnosis (adjusted incidence rate ratio = 0.86; 95% confidence interval: 0.84-0.89, P < 0.001). CONCLUSIONS: Achieving targets for HIV epidemic control will require increasing ART retention and reducing the disparity in retention for those with same-day ART.

High Levels of HIV-1 Drug Resistance in Children Who Acquired HIV Infection Through Mother to Child Transmission in the Era of Option B+, Haiti, 2013 to 2014.

BACKGROUND: The main objective of this study was to determine the frequency and patterns of HIV drug resistance-associated mutations among children under 18 months of age born to HIV-1-positive mothers enrolled in the prevention of mother-to-child transmission services in Haiti. METHODS: Between January 1, 2013 and December 31, 2014, HIV-positive remnant dried blood spots collected from children under 18 months of age for Early Infant Diagnosis at the National Public Health Laboratory were used for HIV-1 genotyping. HIV drug resistance mutations were analyzed using the Stanford Drug Resistance HIVdb program. RESULTS: Of the 3555 dried blood spots collected for Early Infant Diagnosis, 360 (10.1%) were HIV-positive and 355 were available for genotyping. Of these, 304 (85.6%) were successfully genotyped and 217 (71.4%) had ≥1 drug resistance mutation. Mutations conferring resistance to nucleoside reverse transcriptase inhibitor (NRTIs) and non-NRTIs were present in 40.5% (123) and 69.1% (210), respectively. The most frequent mutations were K103N/S (48.0%), M184V (37.5%), G190A/S (15.1%), and Y181C/G/V (14.1%). Predicted drug resistance analysis revealed that 68.8% of the children had high-level resistance to non-NRTIs and 11.5% had intermediate to high-level resistance to abacavir. CONCLUSIONS: This study showed high rates of resistance to NRTIs and non-NRTIs among newly HIV-diagnosed children in Haiti, suggesting that in the era of "Option B+" (initiation of lifelong combination antiretroviral therapy to pregnant women with HIV), the majority of children who acquire HIV infection through mother-to-child transmission of HIV have resistant HIV. These results have led the National HIV Program to revise the pediatric guidelines to include protease inhibitors in first-line regimens for all HIV-positive newborns.

ART Attrition across Health Facilities Implementing Option B+ in Haiti.

BACKGROUND: Describing factors related to high attrition is important in order to improve the implementation of the Option B+ strategy in Haiti. METHODS: We conducted a retrospective cohort study to describe the variability of antiretroviral therapy (ART) retention across health facilities among pregnant and lactating women and assess for differences in ART retention between Option B+ clients and other ART patients. RESULTS: There were 1989 Option B+ clients who initiated ART in 45 health facilities. The percentage of attrition varied from 9% to 81% across the facilities. The largest health facilities had 38% higher risk of attrition (relative risk [RR]: 1.38, 95% confidence interval [CI]: 1.08-1.77, P = .009). Private institutions had 18% less risk of attrition (RR: 0.82, 95% CI: 0.70-0.96, P = .020). Health facilities located in the West department and the South region had lower risk of attrition. CONCLUSION: Being on treatment in a large or public health facility or a facility located in the North region was a significant risk factor associated with high attrition among Option B+ clients. The implementation of the Option B+ strategy must be reevaluated in order to effectively eliminate mother-to-child HIV transmission.

Virologic outcome among patients receiving antiretroviral therapy at five hospitals in Haiti.

INTRODUCTION: Viral load (VL) assessment is the preferred method for diagnosing and confirming virologic failure for patients on antiretroviral therapy (ART). We conducted a retrospective cross-sectional study to evaluate the virologic suppression rate among patients on ART for ≥6 months in five hospitals around Port-au-Prince, Haiti. METHODS: Plasma VL was measured and patients with VL <1,000 copies/mL were defined as virologically suppressed. A second VL test was performed within at least six months of the first test. Factors associated with virologic suppression were analyzed using logistic regression models accounting for site-level clustering using complex survey procedures. RESULTS: Data were analyzed for 2,313 patients on ART for six months or longer between July 2013 and February 2015. Among them, 1,563 (67.6%) achieved virologic suppression at the first VL test. A second VL test was performed within at least six months for 718 (31.0%) of the patients. Of the 459 patients with an initial HIV-1 RNA <1,000 copies/mL who had a second VL performed, 394 (85.8%) maintained virologic suppression. Virologic suppression was negatively associated with male gender (adjusted odds ratio [aOR]: 0.80, 95% CI: 0.74-0.0.86), 23 to 35 months on ART (aOR:0.72[0.54-0.96]), baseline CD4 counts of 201-500 cells/mm3 and 200 cells/mm3 or lower (aORs: 0.77 [0.62-0.95] and 0.80 [0.66-0.98], respectively), poor adherence (aOR: 0.69 [0.59-0.81]), and TB co-infection (aOR: 0.73 [0.55-0.97]). CONCLUSIONS: This study showed that over two-thirds of the patients in this evaluation achieved virologic suppression after ≥ six months on ART and the majority of them remained suppressed. These results reinforce the importance of expanding access to HIV-1 viral load testing in Haiti for monitoring ART outcomes.

The role of service readiness and health care facility factors in attrition from Option B+ in Haiti: a joint examination of electronic medical records and service provision assessment survey data.

Background: Option B+ is a strategy wherein pregnant or breastfeeding women with HIV are enrolled in lifelong antiretroviral therapy (ART) for prevention of mother-to-child transmission (PMTCT) of HIV. In Haiti, attrition from Option B+ is problematic and variable across health care facilities. This study explores service readiness and other facility factors as predictors of Option B+ attrition in Haiti. Methods: This analysis used longitudinal data from 2012 to 2014 from the iSanté electronic medical record system and cross-sectional data from Haiti's 2013 Service Provision Assessment. Predictors included Service Availability and Readiness Assessment (SARA) measures for antenatal care (ANC), PMTCT, HIV care services and ART services; general facility characteristics and patient-level factors. Multivariable Cox proportional hazards models modelled the time to first attrition. Results: Analysis of data from 3147 women at 63 health care facilities showed no significant relationships between SARA measures and attrition. Having integrated ANC/PMTCT care and HIV-related training were significant protective factors. Being a public-sector facility, having a greater number of quality improvement activities and training in ANC were significant risk factors. Conclusion: Several facility-level factors were associated with Option B+ attrition. Future research is needed to explore unmeasured facility factors, clarify causal relationships, and incorporate community-level factors into the analysis of Option B+ attrition.

Retention Throughout the HIV Care and Treatment Cascade: From Diagnosis to Antiretroviral Treatment of Adults and Children Living with HIV-Haiti, 1985-2015.

Monitoring retention of people living with HIV (PLHIV) in the HIV care and treatment cascade is essential to guide program strategy and evaluate progress toward globally-endorsed 90-90-90 targets (i.e., 90% of PLHIV diagnosed, 81% on sustained antiretroviral therapy (ART), and 73% virally suppressed). We describe national retention from diagnosis throughout the cascade for patients receiving HIV services in Haiti during 1985-2015, with a focus on those receiving HIV services during 2008-2015. Among the 266,256 newly diagnosed PLHIV during 1985-2015, 49% were linked-to-care, 30% started ART, and 18% were retained on ART by the time of database closure. Similarly, among the 192,187 newly diagnosed HIV-positive patients during 2008-2015, 50% were linked to care, 31% started ART, and 19% were retained on ART by the time of database closure. Most patients (90-92%) at all cascade steps were adults (≥ 15 years old), among whom the majority (60-61%) were female. During 2008-2015, outcomes varied significantly across 42 administrative districts (arrondissements) of residence; cumulative linkage-to-care ranged from 23% to 69%, cumulative ART initiation among care enrollees ranged from 2% to 80%, and cumulative ART retention among ART enrollees ranged from 30% to 88%. Compared with adults, children had lower cumulative incidence of ART initiation among care enrollees (64% versus 47%) and lower cumulative retention among ART enrollees (64% versus 50%). Cumulative linkage-to-care was low and should be prioritized for improvement. Variations in outcomes by arrondissement and between adults and children require further investigation and programmatic response.

Trends in Prevalence of Advanced HIV Disease at Antiretroviral Therapy Enrollment - 10 Countries, 2004-2015.

Monitoring prevalence of advanced human immunodeficiency virus (HIV) disease (i.e., CD4+ T-cell count <200 cells/µL) among persons starting antiretroviral therapy (ART) is important to understand ART program outcomes, inform HIV prevention strategy, and forecast need for adjunctive therapies.*,†,§ To assess trends in prevalence of advanced disease at ART initiation in 10 high-burden countries during 2004-2015, records of 694,138 ART enrollees aged ≥15 years from 797 ART facilities were analyzed. Availability of national electronic medical record systems allowed up-to-date evaluation of trends in Haiti (2004-2015), Mozambique (2004-2014), and Namibia (2004-2012), where prevalence of advanced disease at ART initiation declined from 75% to 34% (p<0.001), 73% to 37% (p<0.001), and 80% to 41% (p<0.001), respectively. Significant declines in prevalence of advanced disease during 2004-2011 were observed in Nigeria, Swaziland, Uganda, Vietnam, and Zimbabwe. The encouraging declines in prevalence of advanced disease at ART enrollment are likely due to scale-up of testing and treatment services and ART-eligibility guidelines encouraging earlier ART initiation. However, in 2015, approximately a third of new ART patients still initiated ART with advanced HIV disease. To reduce prevalence of advanced disease at ART initiation, adoption of World Health Organization (WHO)-recommended "treat-all" guidelines and strategies to facilitate earlier HIV testing and treatment are needed to reduce HIV-related mortality and HIV incidence.

Attrition from antiretroviral treatment services among pregnant and non-pregnant patients following adoption of Option B+ in Haiti.

BACKGROUND: Access to antiretroviral therapy (ART) has expanded in Haiti because of the adoption of Option B+ and the revision of treatment guidelines. Retention in care and treatment varies greatly and few studies have examined retention rates, particularly among women enrolled in Option B+. OBJECTIVE: To assess attrition among pregnant and non-pregnant patients initiating ART following adoption of Option B+ in Haiti. METHODS: Longitudinal data of adult patients initiated on ART from October 2012 through August 2014 at 73 health facilities across Haiti were analyzed using a survival analysis framework to determine levels of attrition. The Kaplan-Meier method and Cox proportional hazards regression were used to examine risk factors associated with attrition. RESULTS: Among 17,059 patients who initiated ART, 7627 (44.7%) were non-pregnant women, 5899 (34.6%) were men, and 3533 (20.7%) were Option B+ clients. Attrition from the ART program was 36.7% at 12 months (95% CI: 35.9-37.5%). Option B+ patients had the highest level of attrition at 50.4% at 12 months (95% CI: 48.6-52.3%). While early HIV disease stage at ART initiation was protective among non-pregnant women and men, it was a strong risk factor among Option B+ clients. In adjusted analyses, key protective factors were older age (p < 0.0001), living near the health facility (p = 0.04), having another known HIV-positive household member (p < 0.0001), having greater body mass index (BMI) (p < 0.0001), pre-ART counseling (p < 0.0001), and Cotrimoxazole prophylaxis during baseline (p < 0.01). Higher attrition was associated with rapidly starting ART after enrollment (p < 0.0001), anemia (p < 0.0001), and regimen tenofovir+lamivudine+nevirapine (TDF+3TC+NVP) (p < 0.001). CONCLUSIONS: ART attrition in Haiti is high among adults, especially among Option B+ patients. Identifying newly initiated patients most at risk for attrition and providing appropriate interventions could help reduce ART attrition.