Prevalence and psychosocial factors associated with self-injurious thoughts among people living with HIV presenting for HIV testing in Mozambique.

Self-injurious thoughts have been associated with psychiatric morbidity and suicide. Little is known about psychosocial factors associated with self-injurious thoughts among people newly diagnosed with HIV in sub-Saharan Africa. This study examined whether food insufficiency, mental health symptoms, or social support were associated with recent self-injurious thoughts among people newly diagnosed with HIV in Mozambique. The sample included 2001 PLWH aged ≥ 18 newly diagnosed with HIV at 10 health clinics in Mozambique between April 2013 and June 2015. Data were collected at time of HIV diagnosis. Multivariable logistic regression modeled the association of social support, affective mental health symptom severity, somatic mental health symptom severity, and food insufficiency on recent self-injurious thoughts. Ten percent of respondents reported recent self-injurious thoughts, which was higher among women than men (11% vs 7%). In multivariable analyses, food insufficiency [adjusted odds ratio (aOR) 1.7 (95% CI 1.3, 2.2)], and low [aORvs no = 4.8, 95% CI 1.7, 13.4) and moderate/high affective symptom severity [aORvs no = 8.7, 95% CI 2.8, 27.6) were associated with greater odds of self-injurious thoughts. Interventions to address self-injurious thoughts should consider accompanying psychosocial stressors. Longitudinal research to examine mechanisms through which psychosocial stressors are associated with self-injurious thoughts is warranted.

Household Decision-Making and HIV Care Continuum Outcomes Among Women Living with HIV in Mozambique.

Gender inequality has been associated with HIV infection among women. Less is known about the relationship between gender inequality and HIV care continuum outcomes. This study assessed whether household decision-making power (DMP), one component of gender inequality, was associated with linkage to HIV care, antiretroviral therapy (ART) initiation, or retention in care among women living with HIV in Mozambique. The sample included 600 women ≥18 years of age newly diagnosed with HIV in Mozambique. Data were collected between April 2013 and June 2016. DMP was assessed with three questions about participation in decisions regarding: major household decisions, routine household decisions, and visits to family. Women who did not contribute to decision making in any domain were categorized as having low DMP. HIV care information was obtained from electronic medical records. Multivariable log-Poisson regression analyses were conducted to assess the relationship between DMP and HIV care continuum outcomes. Almost half (49%) of participants reported medium DMP, followed by high (39%) and low DMP (12%). In multivariable regression analyses, when compared with respondents with medium DMP, those with low DMP had a lower likelihood of retention in care 12 months after diagnosis [adjusted risk ratio (aRR) 0.69 (95% CI 0.49-0.98)]. There was no significant relationship between low DMP and linkage to HIV care or ART initiation. High DMP was not significantly associated with HIV outcomes assessed. Women who report low DMP may face barriers to long-term engagement in HIV care. Interventions to improve retention in care among women should consider the role of household decision making and gender inequality.

Measuring retention in care for HIV-positive pregnant women in Prevention of Mother-to-Child Transmission of HIV (PMTCT) option B+ programs: the Mozambique experience.

BACKGROUND: Failure to retain HIV-positive pregnant women on antiretroviral therapy (ART) leads to increased mortality for the mother and her child. This study evaluated different retention measures for women's engagement along the continuum of care for prevention of mother-to-child transmission (PMTCT) option B+ services in Mozambique. METHODS: We compared 'point' retention (patient's presence in care 12-month post-ART initiation or any time thereafter) with the following definitions: alive and in care 12 month post-ART initiation (Ministry of Health; MOH); attendance at a health facility up to 15-month post-ART initiation (World Health Organization; WHO); alive and in treatment at 1-, 2-, 3-, 6-, 9-, and 12-month post-ART initiation (Inter-Agency Task Team; IATT); and alive and in care 12-month post-ART initiation with ≥75% appointment adherence during follow-up (i.e. 'appointment adherence' retention) or with ≥75% of appointments met on time during follow-up (i.e. 'on-time adherence' retention). Kaplan-Meier survival curves were produced to assess variability in retention rates. We used 'on-time adherence' retention as our reference to estimate sensitivity, specificity, and proportion of misclassified patients. RESULTS: Considering the 'point' retention definition, 16,840 HIV-positive pregnant women enrolled in option B+ PMTCT services were identified as 'retained in care' 12-month post-ART initiation. Of these, 60.3% (95% CI 59.6-61.1), 84.8% (95% CI 84.2-85.3), and 16.4% (95% CI 15.8-17.0) were classified as 'retained in care' using MOH, WHO, and IATT definitions, respectively, and 1.2% (95% CI 1.0-1.4) were classified as 'retained in care' using the '≥75% on-time adherence' definition. All definitions provided specificity rates of ≥98%. The sensitivity rates were 3.0% with 78% of patients misclassified according to the WHO definition and 4.3% with 54% of patients misclassified according to the MOH definition. The 'point' retention definition misclassified 97.6% of patients. Using IATT and 'appointment adherence' retention definitions, sensitivity rates (9.0 and 11.7%, respectively) were also low; however, the proportion of misclassified patients was smaller (15.9 and 18.3%, respectively). CONCLUSION: More stringent definitions indicated lower retention rates for PMTCT programs. Policy makers and program managers should include attendance at follow-up visits when measuring retention in care to better guide planning, scale-up, and monitoring of interventions.

Patterns and Predictors of HIV Status Disclosure in the 12 Months After Diagnosis in Mozambique.

BACKGROUND: HIV disclosure benefits people living with HIV, their partners, and HIV programs. However, data on the prevalence of disclosure and associated correlates have come largely from patients already in HIV care, potentially overestimating disclosure rates and precluding examination of the impact of disclosure on HIV care outcomes. SETTING: We used data from an implementation study conducted in Maputo City and Inhambane Province, Mozambique. Adults were enrolled at HIV testing clinics after diagnosis and traced in the community 1 and 12 months later when they reported on disclosure and other outcomes. METHODS: We examined patterns of participants' disclosure to their social networks (N = 1573) and sexual partners (N = 1024) at both follow-up assessments and used relative risk regression to identify correlates of nondisclosure. RESULTS: Disclosure to one's social network and sexual partners was reported by 77.8% and 57.7% of participants, respectively, at 1 month and 92.9% and 72.4% of participants, respectively, at 12 months. At both time points, living in Inhambane Province, being single or not living with a partner, having high levels of anticipated stigma, and not initiating HIV treatment were associated with increased risks of nondisclosure to social networks. Nondisclosure to sexual partners at both follow-up assessments was associated with being women, living in Inhambane Province and in a household without other people living with HIV, and reporting that posttest counseling addressed disclosure. CONCLUSIONS: Although reported disclosure to social networks was high, disclosure to sexual partners was suboptimal. Effective and acceptable approaches to support partner disclosure, particularly for women, are needed.

PMTCT care cascade and factors associated with attrition in the first four years after Option B+ implementation in Mozambique.

OBJECTIVE: To evaluate the effectiveness of the prevention of mother-to-child transmission (PMTCT) Option B+ programme in two provinces with high human immunodeficiency virus (HIV) burden in Mozambique over the first four years of programme implementation. METHODS: We assessed the PMTCT cascade in antenatal care (ANC) from July 2013 to December 2017 using facility-level data and performed a retrospective cohort analysis with patient-level data. We compared the 12-month antiretroviral therapy (ART) retention rates between women with HIV infection who initiated ART under Option B+ ('B+ pregnant') and those who initiated ART for their own health ('own health'). RESULTS: A total of 916 280 pregnant women enrolled in ANC. The proportion of women with a documented HIV status increased from 93% in 2013 to 96% in 2017. The proportion of those tested HIV-positive decreased from 8% to 6% while that of those HIV-positive on ART increased from 42% to 95%. Of the 44 377 HIV-positive women included in the analysis, 35% were lost to care. 'B+ pregnant' women initiating ART in 2015 were less likely to have no follow-up (NFU) compared with 'own health' women starting ART during the same period (adjusted odds ratio: 0.77, 95% confidence interval [CI]: 0.64-0.94, P = 0.01). There was no statistical difference between the two groups during the other years in which ART was initiated. Of those returning for care after their first visit (N = 39 801), the 'B+ pregnant' women showed a higher risk of non-retention than the other group (adjusted hazard ratio: 1.14, 95% CI: 1.03-1.25) when ART was initiated in 2013. The risk decreased during the subsequent years, with no difference observed between the groups. CONCLUSION: PMTCT Option B+ programme scale-up has yielded positive results, including the maintenance of high HIV testing and ART initiation rates in ANC. Challenges still remain, however, in improving immediate engagement in care and long-term retention. Seeking alternative service delivery models to support existing health systems and prevent defaulters is required to achieve the UNAIDS 95-95-95 targets for PMTCT in Mozambique.

OBJECTIF: Evaluer l'efficacité du programme de la prévention de la transmission mère-enfant (PTME) Option B+ dans deux provinces avec une charge élevée du virus de l' immunodéficience humaine (VIH) au Mozambique, au cours des quatre premières années de la mise en œuvre du programme. MÉTHODES: Nous avons évalué la cascade PTME dans les soins des cliniques prénatales (SCP) de juillet 2013 à décembre 2017 à l'aide de données à l'échelle de l'établissement et avons effectué une analyse de cohorte rétrospective avec des données à l'échelle du patient. Nous avons comparé les taux de rétention à 12 mois de la thérapie antirétrovirale (ART) entre les femmes infectées par le VIH qui ont commencé l'ART dans le cadre de l'option B+ (''enceintes B+'') et celles qui ont commencé l'ART pour leur propre santé (''propre santé''). RÉSULTATS: Au total, 916.280 femmes enceintes ont été inscrites dans les SCP. La proportion de femmes avec un statut VIH documenté est passée de 93% en 2013 à 96% en 2017. La proportion de celles testées positives pour le VIH est passée de 8% à 6% tandis que celle des femmes positives au VIH sous ART est passée de 42% à 95%. Sur les 44.377 femmes séropositives incluses dans l'analyse, 35% ont été perdues au cours des soins. Les femmes ''enceintes B+'' qui ont commencé l'ART en 2015 étaient moins susceptibles de ne pas avoir de suivi (NFU) que les femmes ''propre santé'' ayant commencé l'ART au cours de la même période (rapport de cotes ajusté: 0,77 ; intervalle de confiance à 95% [IC]: 0,64-0,94 ; P = 0,01). Il n'y avait aucune différence statistique entre les deux groupes durant les autres années au cours desquelles l'ART a été initiée. Parmi celles retournant pour des soins après leur première visite (N = 39.801), les femmes ''enceintes B+'' présentaient un risque plus élevé de non-rétention que l'autre groupe (rapport de risque ajusté: 1,14 ; IC95%: 1,03-1,25) lorsque l'ART a été initiée en 2013. Le risque diminuait au cours des années suivantes, sans différence observée entre les groupes. CONCLUSION: Le déploiement du programme PTME Option B+ a donné des résultats positifs, notamment le maintien de taux élevés de dépistage du VIH et d'initiation de l'ART dans les SCP. Il reste cependant des défis à relever pour améliorer l'engagement immédiat dans les soins et la rétention à long terme. La recherche de modèles de prestation de services alternatifs pour soutenir les systèmes de santé existants et prévenir les défaillances est nécessaire pour atteindre les objectifs de l'ONUSIDA 95-95-95 pour la PTME au Mozambique.

Factors Associated with Use of Short-Term Pre-Exposure Prophylaxis for HIV Among Female Partners of Migrant Miners in Mozambique.

Effective interventions tailored to specific types of behaviors and contexts are needed for women at risk for HIV acquisition. Oral pre-exposure prophylaxis (PrEP) is an efficacious HIV prevention intervention that uses antiretroviral drugs to reduce the risk of acquiring HIV infection. In Mozambique, HIV remains a major public health concern, with a national prevalence of 13%. Studies have demonstrated that the migration of male miners between southern provinces of Mozambique and South Africa is contributing to the HIV epidemic in Mozambique. This increased risk is associated with the engagement of male miners, while separated from their partners, in sexual relationships with other women, including transactional sex workers, in a hyperendemic setting in South Africa. We conducted 25 in-depth interviews with a subset of female partners in a stable relationship with migrant miners participating in a prospective cohort study to assess the feasibility, acceptability, and adherence to daily oral short-term PrEP. Drug levels were available for the participants, as reported in an earlier study. Interviews were recorded, transcribed, and submitted for qualitative thematic analysis. The major themes identified were the benefits of taking PrEP, the ease of taking daily PrEP, the reluctance to disclose PrEP use to partners, the lack of changes in sexual behavior, and prevailing gender dynamics and how they impact women's ability to access PrEP and other HIV prevention interventions.

A combination intervention strategy to improve linkage to and retention in HIV care following diagnosis in Mozambique: A cluster-randomized study.

BACKGROUND: Concerning gaps in the HIV care continuum compromise individual and population health. We evaluated a combination intervention strategy (CIS) targeting prevalent barriers to timely linkage and sustained retention in HIV care in Mozambique. METHODS AND FINDINGS: In this cluster-randomized trial, 10 primary health facilities in the city of Maputo and Inhambane Province were randomly assigned to provide the CIS or the standard of care (SOC). The CIS included point-of-care CD4 testing at the time of diagnosis, accelerated ART initiation, and short message service (SMS) health messages and appointment reminders. A pre-post intervention 2-sample design was nested within the CIS arm to assess the effectiveness of CIS+, an enhanced version of the CIS that additionally included conditional non-cash financial incentives for linkage and retention. The primary outcome was a combined outcome of linkage to care within 1 month and retention at 12 months after diagnosis. From April 22, 2013, to June 30, 2015, we enrolled 2,004 out of 5,327 adults ≥18 years of age diagnosed with HIV in the voluntary counseling and testing clinics of participating health facilities: 744 (37%) in the CIS group, 493 (25%) in the CIS+ group, and 767 (38%) in the SOC group. Fifty-seven percent of the CIS group achieved the primary outcome versus 35% in the SOC group (relative risk [RR]CIS vs SOC = 1.58, 95% CI 1.05-2.39). Eighty-nine percent of the CIS group linked to care on the day of diagnosis versus 16% of the SOC group (RRCIS vs SOC = 9.13, 95% CI 1.65-50.40). There was no significant benefit of adding financial incentives to the CIS in terms of the combined outcome (55% of the CIS+ group achieved the primary outcome, RRCIS+ vs CIS = 0.96, 95% CI 0.81-1.16). Key limitations include the use of existing medical records to assess outcomes, the inability to isolate the effect of each component of the CIS, non-concurrent enrollment of the CIS+ group, and exclusion of many patients newly diagnosed with HIV. CONCLUSIONS: The CIS showed promise for making much needed gains in the HIV care continuum in our study, particularly in the critical first step of timely linkage to care following diagnosis. TRIAL REGISTRATION: ClinicalTrials.gov NCT01930084.

Advanced Human Immunodeficiency Virus Disease at Diagnosis in Mozambique and Swaziland.

BACKGROUND: Early diagnosis of human immunodeficiency virus (HIV) is a prerequisite to maximizing individual and societal benefits of antiretroviral therapy. METHODS: Adults ≥18 years of age testing HIV positive at 10 health facilities in Mozambique and Swaziland received point-of-care CD4+ cell count testing immediately after diagnosis. We examined median CD4+ cell count at diagnosis, the proportion diagnosed with advanced HIV disease (CD4+ cell count ≤350 cells/µL) and severe immunosuppression (CD4+ cell count ≤100 cells/µL), and determinants of the latter 2 measures. RESULTS: Among 2333 participants, the median CD4+ cell count at diagnosis was 313 cells/µL (interquartile range, 164-484), more than half (56.5%) had CD4+ ≤350 cells/µL, and 13.9% had CD4+ ≤100 cells/µL. The adjusted relative risk (aRR) of both advanced HIV disease and severe immunosuppression at diagnosis was higher in men versus women (advanced disease aRR = 1.31; 95% confidence interval [CI] = 1.16-1.48; severe immunosuppression aRR = 1.54, 95% CI = 1.17-2.02) and among those who sought HIV testing because they felt ill (advanced disease aRR = 1.30, 95% CI = 1.08-1.55; severe immunosuppression aRR = 2.10, 95% CI = 1.35-2.26). Age 18-24 versus 25-39 was associated with a lower risk of both outcomes (advanced disease aRR = 0.70, 95% CI = 0.59-0.84; severe immunosuppression aRR = 0.62, 95% CI = 0.41-0.95). CONCLUSIONS: More than 10 years into the global scale up of comprehensive HIV services, the majority of adults diagnosed with HIV at health facilities in 2 high-prevalence countries presented with advanced disease and 1 in 7 had severe immunosuppression. Innovative strategies for early identification of HIV-positive individuals are urgently needed.

Feasibility, Acceptability, and Adherence with Short-Term HIV Preexposure Prophylaxis in Female Sexual Partners of Migrant Miners in Mozambique.

BACKGROUND: Preexposure prophylaxis (PrEP) offers protection from HIV acquisition if taken as prescribed. We evaluated the feasibility, acceptability, and adherence with short-term PrEP among female sexual partners of migrant miners in Mozambique. METHODS: HIV-negative female sexual partners of migrant miners were offered daily tenofovir/emtricitabine (TDF/FTC) for 6 weeks concurrent with miners' return home. Study visits occurred at baseline, week 4, 6, and 8. Dried blood spots (DBSs) were collected at week 4 and 6. RESULTS: Seventy-four women (median age: 42 years) were enrolled, 95% reported having 1 sexual partner and 80% reported never or rarely using condoms. At baseline, 41% had never tested for HIV; 65% were unaware of partners' HIV status. Of all women, 72 (97%) initiated PrEP, 7 (9%) discontinued PrEP before week 6; only 1 due to adverse events. Missed doses in the last week were self-reported by 8% and 3% of women at week 4 and 6, respectively. Of 66 (89%) women with DBS at week 4, 79% had detectable tenofovir diphosphate (TFV-DP) and 44% had levels consistent with ≥4 pills/wk (≥700 fmol/punch). Of 63 (88%) women with DBS at week 6, 76% had detectable TFV-DP and 42% had levels consistent with ≥4 pills/wk. CONCLUSIONS: In this first study assessing the use of short-term PrEP, a high percent of female partners of migrant workers initiated PrEP and had detectable DP levels during follow-up. Further efforts are needed to enhance adherence to ensure protection from HIV acquisition. Short-term PrEP offers promise for populations who are at high risk of HIV during specific periods of time.

Willingness to use short-term oral pre-exposure prophylaxis (PrEP) by migrant miners and female partners of migrant miners in Mozambique.

Migrant miners from Mozambique who work in South Africa and their partners are at substantial risk for HIV infection. We conducted a cross-sectional study to assess the willingness of migrant miners and female partners of miners to take short-term pre-exposure prophylaxis (PrEP) for prevention of HIV acquisition. The study was conducted in Gaza Province, Mozambique, between September and October 2015. A total of 131 male miners and female partners of male miners completed a questionnaire. Subsequently, 48 in-depth interviews among male miners and female partners of miners and 3 focus-group discussions (6 participants each) among female partners of miners were conducted. Quantitative data were tabulated using Stata. A structured coding scheme was developed and qualitative data were analysed using Atlas.ti. Most participants (94%) were willing to take PrEP for short-term use. Facilitating factors for willingness to use PrEP were concerns about partner's sexual behaviour, desire for pregnancy and one's own sexual behaviour. The main barriers to PrEP use were concerns regarding side-effects, perceived difficulty adhering to daily pill taking and concern about partner/family disapproval. Overall, participants saw potential barriers for PrEP as minor obstacles that could be overcome. The male partner's influence on PrEP use was significant.

Informing efforts to reach UNAIDS' 90-90-90 targets: a comparison of characteristics of people diagnosed with HIV in health facilities to the general population of people living with HIV in Mozambique.

Global targets aim to increase the number of people living with HIV (PLWH) who know their status. Using data from Mozambican facility-based HIV testing and counseling (HTC) and a population-based survey, we compared characteristics of PLWH diagnosed in HTC to the general population of PLWH to identify subgroups that are missing from the health system and may be undiagnosed. Male and female PLWH aged 50+ (PPR = 0.47, p = .0001) and with higher HIV knowledge (PPR = 0.52, p = .004) were underrepresented in HTC. A higher proportion of patients diagnosed in health facilities were aged 25-39 (PPR = 1.23, p = .02). Female PLWH with lower economic (PPR = 0.70, p = .04) and educational status (PPR = 0.86, p = .02) and male PLWH aged 18-24 (PPR = 0.47, p = .03) were underrepresented in HTC. Comparing HTC data to population-based data can inform efforts to increase HIV diagnoses and to ensure that all PLWH know their status.

Feasibility and Acceptability of Health Communication Interventions Within a Combination Intervention Strategy for Improving Linkage and Retention in HIV Care in Mozambique.

BACKGROUND: Challenges to ensuring timely linkage to and retention in HIV care are well documented. Combination intervention strategies can be effective in improving the HIV care continuum. Data on feasibility and acceptability of intervention types within intervention packages are limited. METHODS: The Engage4Health study assessed the effectiveness of a combination intervention strategy to increase linkage and retention among adults newly diagnosed with HIV in Mozambique. The study included 2 health communication interventions-modified delivery of pre-antiretroviral therapy (pre-ART) counseling sessions and SMS reminders-and 3 structural interventions-point-of-care CD4 testing after diagnosis, accelerated ART initiation, and noncash financial incentives. We used a process evaluation framework to assess dose delivered-extent each intervention was delivered as planned-and dose received-participant acceptability-of health communication versus structural interventions in the effectiveness study to understand associated benefits and challenges. Data sources included study records, participant interviews, and clinical data. RESULTS: For dose delivered of health communication interventions, 98% of eligible clients received pre-ART counseling and 90% of participants received at least one SMS reminder. For structural interventions, 74% of clients received CD4 testing and 53% of eligible participants initiated ART within 1 month. Challenges for structural interventions included facility-level barriers, staffing limitations, and machine malfunctions. For dose received, participants reported pre-ART counseling and CD4 testing as the most useful interventions for linkage and financial incentives as the least useful for linkage and retention. DISCUSSION: Findings demonstrate that health communication interventions can be feasibly and acceptably integrated with structural interventions to create combination intervention strategies.

How Can the Health System Retain Women in HIV Treatment for a Lifetime? A Discrete Choice Experiment in Ethiopia and Mozambique.

INTRODUCTION: Option B+, an approach that involves provision of antiretroviral therapy (ART) to all HIV-infected pregnant women for life, is the preferred strategy for prevention of mother to child transmission of HIV. Lifelong retention in care is essential to its success. We conducted a discrete choice experiment in Ethiopia and Mozambique to identify health system characteristics preferred by HIV-infected women to promote continuity of care. METHODS: Women living with HIV and receiving care at hospitals in Oromia Region, Ethiopia and Zambézia Province, Mozambique were shown nine choice cards and asked to select one of two hypothetical health facilities, each with six varying characteristics related to the delivery of HIV services for long term treatment. Mixed logit models were used to estimate the influence of six health service attributes on choice of clinics. RESULTS: 2,033 women participated in the study (response rate 97.8% in Ethiopia and 94.7% in Mozambique). Among the various attributes of structure and content of lifelong ART services, the most important attributes identified in both countries were respectful provider attitude and ability to obtain non-HIV health services during HIV-related visits. Availability of counseling support services was also a driver of choice. Facility type, i.e., hospital versus health center, was substantially less important. CONCLUSIONS: Efforts to enhance retention in HIV care and treatment for pregnant women should focus on promoting respectful care by providers and integrating access to non-HIV health services in the same visit, as well as continuing to strengthen counseling.

Monitoring quality at scale: implementing quality assurance in a diverse, multicountry HIV program.

The centrality of quality as a strategy to achieve impact within the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) has been widely recognized. However, monitoring program quality remains a challenge for many HIV programs, particularly those in resource-limited settings, where human resource constraints and weaker health systems can pose formidable barriers to data collection and interpretation. We describe the practicalities of monitoring quality at scale within a very large multicountry PEPFAR-funded program, based largely at health facilities. The key elements include the following: supporting national programs and strategies; developing a conceptual framework and programmatic model to define quality and guide the provision of high-quality services; attending to program context, as well as program outcomes; leveraging existing and routinely collected data whenever possible; developing additional indicators for judicious use in targeted, in-depth assessments; providing hands-on support for data collection and use at the facility, sub-national, and national levels; utilizing web-based databases for data entry, analysis, and dissemination; and multidisciplinary support from a large team of clinical and strategic information advisors.

A combination strategy for enhancing linkage to and retention in HIV care among adults newly diagnosed with HIV in Mozambique: study protocol for a site-randomized implementation science study.

BACKGROUND: Despite the extraordinary scale up of HIV prevention, care and treatment services in sub-Saharan Africa (SSA) over the past decade, the overall effectiveness of HIV programs has been significantly hindered by high levels of attrition across the HIV care continuum. Data from "real-life" settings are needed on the effectiveness of an easy to deliver package of services that can improve overall performance of the HIV care continuum. METHODS/DESIGN: We are conducting an implementation science study using a two-arm cluster site-randomized design to determine the effectiveness of a combination intervention strategy (CIS) using feasible, evidence-based, and practical interventions-including (1) point-of-care (POC) CD4 count testing, (2) accelerated antiretroviral therapy initiation for eligible individuals, and (3) SMS reminders for linkage to and retention in care-as compared to the standard of care (SOC) in Mozambique in improving linkage and retention among adults following HIV diagnosis. A pre-post intervention two-sample design is nested within the CIS arm to assess the incremental effectiveness of the CIS plus financial incentives (CIS + FI) compared to the CIS without FI on study outcomes. Randomization is done at the level of the study site, defined as a primary health facility. Five sites are included from the City of Maputo and five from Inhambane Province. Target enrollment is a total of 2,250 adults: 750 in the SOC arm, 750 in the CIS cohort of the intervention arm and 750 in the CIS + FI cohort of the intervention arm (average of 150 participants per site). Participants are followed for 12 months from time of HIV testing to ascertain a combined endpoint of linkage to care within 1 month after testing and retention in care 12 months from HIV test. Cost-effectiveness analyses of CIS compared to SOC and CIS + FI compared to CIS will also be conducted. DISCUSSION: Study findings will provide evidence on the effectiveness of a CIS and the incremental effectiveness of a CIS + FI in a "real-life" service delivery system in a SSA country severely impacted by HIV. TRIAL REGISTRATION: Clinicaltrials.gov, NCT01930084.

A combination strategy for enhancing linkage to and retention in HIV care among adults newly diagnosed with HIV in Mozambique: study protocol for a site-randomized implementation science study

Background: Despite the extraordinary scale up of HIV prevention, care and treatment services in sub-Saharan Africa (SSA) over the past decade, the overall effectiveness of HIV programs has been significantly hindered by high levels of attrition across the HIV care continuum. Data from "real-life" settings are needed on the effectiveness of an easy to deliver package of services that can improve overall performance of the HIV care continuum. Methods/Design: We are conducting an implementation science study using a two-arm cluster site-randomized design to determine the effectiveness of a combination intervention strategy (CIS) using feasible, evidence-based, and practical interventions­including (1) point-of-care (POC) CD4 count testing, (2) accelerated antiretroviral therapy initiation for eligible individuals, and (3) SMS reminders for linkage to and retention in care­as compared to the standard of care (SOC) in Mozambique in improving linkage and retention among adults following HIV diagnosis. A pre-post intervention two-sample design is nested within the CIS arm to assess the incremental effectiveness of the CIS plus financial incentives (CIS + FI) compared to the CIS without FI on study outcomes. Randomization is done at the level of the study site, defined as a primary health facility. Five sites are included from the City of Maputo and five from Inhambane Province. Target enrollment is a total of 2,250 adults: 750 in the SOC arm, 750 in the CIS cohort of the intervention arm and 750 in the CIS + FI cohort of the intervention arm (average of 150 participants per site). Participants are followed for 12 months from time of HIV testing to ascertain a combined endpoint of linkage to care within 1 month after testing and retention in care 12 months from HIV test. Cost-effectiveness analyses of CIS compared to SOC and CIS + FI compared to CIS will also be conducted. Discussion: Study findings will provide evidence on the effectiveness of a CIS and the incremental effectiveness of a CIS + FI in a "real-life" service delivery system in a SSA country severely impacted by HIV

Immunovirological response to combined antiretroviral therapy and drug resistance patterns in children: 1- and 2-year outcomes in rural Uganda.

BACKGROUND: Children living with HIV continue to be in urgent need of combined antiretroviral therapy (ART). Strategies to scale up and improve pediatric HIV care in resource-poor regions, especially in sub-Saharan Africa, require further research from these settings. We describe treatment outcomes in children treated in rural Uganda after 1 and 2 years of ART start. METHODS: Cross-sectional assessment of all children treated with ART for 12 (M12) and 24 (M24) months was performed. CD4 counts, HIV RNA levels, antiretroviral resistance patterns, and non-nucleoside reverse transcriptase inhibitor (NNRTI) plasma concentrations were determined. Patient adherence and antiretroviral-related toxicity were assessed. RESULTS: Cohort probabilities of retention in care were 0.86 at both M12 and M24. At survey, 71 (83%, M12) and 32 (78%, M24) children remained on therapy, and 84% participated in the survey. At ART start, 39 (45%) were female; median age was 5 years. Median initial CD4 percent was 11% [IQR 9-15] in children < 5 years old (n = 12); CD4 count was 151 cells/mm(3) [IQR 38-188] in those ≥ 5 years old (n = 26). At M12, median CD4 gains were 11% [IQR 10-14] in patients < 5 years old, and 206 cells/mm(3) [IQR 98-348] in ≥ 5 years old. At M24, median CD4 gains were 11% [IQR 5-17] and 132 cells/mm(3) [IQR 87-443], respectively. Viral suppression (< 400 copies/mL) was achieved in 59% (M12) and 33% (M24) of children. Antiretroviral resistance was found in 25% (M12) and 62% (M24) of children. Overall, 29% of patients had subtherapeutic NNRTI plasma concentrations. CONCLUSIONS: After one year of therapy, satisfactory survival and immunological responses were observed, but nearly 1 in 4 children developed viral resistance and/or subtherapeutic plasma antiretroviral drug levels. Regular weight-adjustment dosing and strategies to reinforce and maintain ART adherence are essential to maximize duration of first-line therapy in children in resource-limited countries.

Nutrition outcomes of HIV-infected malnourished adults treated with ready-to-use therapeutic food in sub-Saharan Africa: a longitudinal study.

BACKGROUND: Among people living with HIV/AIDS, nutritional support is increasingly recognized as a critical part of the essential package of care, especially for patients in sub-Saharan Africa. The objectives of the study were to evaluate the outcomes of HIV-positive malnourished adults treated with ready-to-use therapeutic food and to identify factors associated with nutrition programme failure. METHODS: We present results from a retrospective cohort analysis of patients aged 15 years or older with a body mass index of less than 17 kg/m² enrolled in three HIV/AIDS care programmes in Africa between March 2006 and August 2008. Factors associated with nutrition programme failure (patients discharged uncured after six or more months of nutritional care, defaulting from nutritional care, remaining in nutritional care for six or more months, or dead) were investigated using multiple logistic regression. RESULTS: Overall, 1340 of 8685 (15.4%) HIV-positive adults were enrolled in the nutrition programme. At admission, median body mass index was 15.8 kg/m² (IQR 14.9-16.4) and 12% received combination antiretroviral therapy (ART). After a median of four months of follow up (IQR 2.2-6.1), 524 of 1106 (47.4%) patients were considered cured. An overall total of 531 of 1106 (48.0%) patients failed nutrition therapy, 132 (11.9%) of whom died and 250 (22.6%) defaulted from care. Men (OR = 1.5, 95% CI 1.2-2.0), patients with severe malnutrition at nutrition programme enrolment (OR = 2.2, 95% CI 1.7-2.8), and those never started on ART (OR = 4.5, 95% CI 2.7-7.7 for those eligible; OR = 1.6, 95% CI 1.0-2.5 for those ineligible for ART at enrolment) were at increased risk of nutrition programme failure. Diagnosed tuberculosis at nutrition programme admission or during follow up, and presence of diarrhoeal disease or extensive candidiasis at admission, were unrelated to nutrition programme failure. CONCLUSIONS: Concomitant administration of ART and ready-to-use therapeutic food increases the chances of nutritional recovery in these high-risk patients. While adequate nutrition is necessary to treat malnourished HIV patients, development of improved strategies for the management of severely malnourished patients with HIV/AIDS are urgently needed.

Evaluation of a 5-year programme to prevent mother-to-child transmission of HIV infection in Northern Uganda.

Prevention of mother-to-child transmission (PMTCT) is essential in HIV/AIDS control. We analysed 2000-05 data from mother-infant pairs in our PMTCT programme in rural Uganda, examining programme utilization and outcomes, HIV transmission rates and predictors of death or loss to follow-up (LFU). Out of 19,017 women, 1,037 (5.5%) attending antenatal care services tested HIV positive. Of these, 517 (50%) enrolled in the PMTCT programme and gave birth to 567 infants. Before tracing, 303 (53%) mother-infant pairs were LFU. Reasons for dropout were infant death and lack of understanding of importance of follow-up. Risk of death or LFU was higher among infants with no or incomplete intrapartum prophylaxis (OR = 1.90, 95% CI 1.07-3.36) and of weaning age <6 months (OR 2.55, 95% CI 1.42-4.58), and lower in infants with diagnosed acute illness (OR 0.30, 95% CI 0.16-0.55). Mother-to-child HIV cumulative transmission rate was 8.3%, and 15.5% when HIV-related deaths were considered. Improved tracking of HIV-exposed infants is needed in PMTCT programmes where access to early infant diagnosis is still limited.