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Background: Cascades have been used to characterize sequential steps within a complex health system and are used in diverse disease areas and across prevention, testing, and treatment. Routine data have great potential to inform prioritization within a system, but are often inaccessible to frontline health care workers (HCWs) who may have the greatest opportunity to innovate health system improvement., Methods: The cascade analysis tool (CAT) is an Excel-based, simple simulation model with an optimization function. It identifies the step within a cascade that could most improve the system. The original CAT was developed for HIV treatment and the prevention of mother-to-child transmission of HIV., Results: CAT has been adapted 7 times: to a mobile application for prevention of mother-to-child transmission; for hypertension screening and management and for mental health outpatient services in Mozambique; for pediatric and adolescent HIV testing and treatment, HIV testing in family planning, and cervical cancer screening and treatment in Kenya; and for naloxone distribution and opioid overdose reversal in the United States. The main domains of adaptation have been technical-estimating denominators and structuring steps to be binary sequential steps-as well as logistical-identifying acceptable approaches for data abstraction and aggregation, and not overburdening HCW., Discussion: CAT allows for prompt feedback to HCWs, increases HCW autonomy, and allows managers to allocate resources and time in an equitable manner. CAT is an effective, feasible, and acceptable implementation strategy to prioritize areas most requiring improvement within complex health systems, although adaptations are being currently evaluated.

Background: This randomized trial studied performance of Option B+ in Mozambique and evaluated an enhanced retention package in public clinics., Setting: The study was conducted at 6 clinics in Manica and Sofala Provinces in central Mozambique., Methods: Seven hundred sixty-one pregnant women tested HIV+, immediately initiated antiretroviral (ARV) therapy, and were followed to track retention at 6 clinics from May 2014 to May 2015. Clinics were randomly allocated within a stepped-wedge fashion to intervention and control periods. The intervention included (1) workflow modifications and (2) active patient tracking. Retention was defined as percentage of patients returning for 30-, 60-, and 90-day medication refills within 25-35 days of previous refills., Results: During control periods, 52.3% of women returned for 30-day refills vs. 70.8% in intervention periods [odds ratio (OR): 1.80; 95% confidence interval (CI): 1.05 to 3.08]. At 60 days, 46.1% control vs. 57.9% intervention were retained (OR: 1.82; CI: 1.06 to 3.11), and at 90 days, 38.3% control vs. 41.0% intervention (OR: 1.04; CI: 0.60 to 1.82). In prespecified subanalyses, birth before pickups was strongly associated with failure-women giving birth before ARV pickup were 33.3 times (CI: 4.4 to 250.3), 7.5 times (CI: 3.6 to 15.9), and 3.7 times (CI: 2.2 to 6.0) as likely to not return for ARV pickups at 30, 60, and 90 days, respectively., Conclusions: The intervention was effective at 30 and 60 days, but not at 90 days. Combined 90-day retention (40%) and adherence (22.5%) were low. Efforts to improve retention are particularly important for women giving birth before ARV refills.

Background: Despite effective prevention strategies and increasing investments in global health, maternal to child transmission (MTCT) of HIV remains a significant problem globally, especially in sub-Saharan Africa. In 2012, there were 94,000 HIV-positive pregnant women in Mozambique. Approximately 15% of these women transmitted HIV to their newborn infants, resulting in nearly 14,000 new pediatric HIV infections that year. To address this issue, in 2013, the Mozambican Ministry of Health implemented the World Health Organization-recommended "Option B+" strategy in which all newly diagnosed HIV-positive pregnant women are counseled to initiate combination anti-retroviral therapy (ART) immediately upon diagnosis regardless of CD4 count and to continue treatment for life. Given the limited experience with Option B+ in sub-Saharan Africa, few rigorous pragmatic trials have studied this new treatment strategy., Methods: This study utilizes an initial formative research process involving patient and health care provider interviews and focus groups, workforce assessments, value stream mapping, and commodity utilization assessments to understand the strengths and weaknesses in the current Option B+ care cascade. The formative research is intended to guide identification and prioritization of key workflow modifications and the development of an enhanced adherence and retention package. These two components are bundled into a defined intervention implemented and evaluated across six health facilities utilizing a stepped wedge randomized controlled trial study design. The overall objective of this trial is to develop and test a pilot intervention in central Mozambique to implement the new Option B+ guidelines with high fidelity and increase the proportion of HIV-positive pregnant women in target antenatal clinics (ANC) who start ART prior to delivery and are retained in care., Discussion: This pragmatic study utilizes research strategies that have the potential to meaningfully improve the Option B+ care cascade in central Mozambique and to decrease the MTCT of HIV. This trial is designed to identify critical low-cost improvement strategies that can be bundled into a defined intervention. If this intervention has a measurable impact, it can be rapidly scaled up to other ANC in Mozambique and sub-Saharan Africa., Trial Registration: ClinicalTrials.gov: NCT02371265.

Background: Task shifting is a common strategy to deliver antiretroviral therapy (ART) in resource-limited settings and is safe and effective if implemented appropriately. Consensus among stakeholders is necessary to formulate clear national policies that maintain high-quality care. We sought to understand key stakeholders' opinions regarding task shifting of HIV care in Mozambique and to characterize which specific tasks stakeholders considered appropriate for specific cadres of health workers., Methods: National and provincial Ministry of Health leaders, representatives from donor and non-governmental organizations (NGOs), and clinicians providing HIV care were intentionally selected to represent diverse viewpoints. Using open- and closed-ended questions, interviewees were asked about their general support of task shifting, its potential advantages and disadvantages, and whether each of seven cadres of non-physician health workers should perform each of eight tasks related to ART provision. Responses were tallied overall and stratified by current job category. Interviews were conducted between November 2007 and June 2008., Results: Of 62 stakeholders interviewed, 44% held leadership positions in the Ministry of Health, 44% were clinicians providing HIV care, and 13% were donors or employed by NGOs; 89% held a medical degree. Stakeholders were highly supportive of physician assistants performing simple ART-related tasks and unanimous in opposing community health workers providing any ART-related services. The most commonly cited motives to implement task shifting were to increase ART access, decrease physician workload, and decrease patient wait time, whereas chief concerns included reduced quality of care and poor training and supervision. Support for task shifting was higher among clinicians than policy and programme leaders for three specific task/cadre combinations: general mid-level nurses to initiate ART in adults (supported by 75% of clinicians vs. 41% of non-clinicians) and in pregnant women (75% vs. 34%, respectively) and physician assistants to change ART regimens in adults (43% vs. 24%, respectively)., Conclusions: Stakeholders agreed on some ART-related task delegation to lower health worker cadres. Clinicians were more likely to support task shifting than policy and programme leaders, perhaps motivated by their front-line experiences. Harmonizing policy and programme managers' views with those of clinicians will be important to formulate and implement clear policy.

Acquisition of nevirapine (NVP)-resistant human immunodeficiency virus type 1 (HIV-1) by breast-feeding infants after receipt of single-dose NVP to prevent mother-to-child transmission is not well defined. A prospective observational study of 307 infants evaluated the rate of breast milk transmission of NVP-resistant HIV and the concentrations of mutants over time. NVP resistance was detected in 9 of 24 infants (37.5%; 95% confidence interval, 18.8%-59.4%) infected via breast milk. Eight had a pure mutant HIV population at the time infection was first detected, and majority mutant populations persisted in all 6 infants with follow-up specimens. Infection of breast-feeding infants with NVP-resistant HIV resulted in mutants persisting as the dominant virus, which may indefinitely compromise treatment with NVP-based antiretroviral regimens., (© The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.)

Background: Access to antiretroviral therapy (ART) has increased dramatically in resource-limited settings since its introduction a decade ago. However, ART coverage remains low in countries with the highest disease burden, which may be partially explained by poor testing to care linkages. HIV testing service may impact early attrition in the HIV treatment cascade., Methods: A retrospective cohort study was conducted in 18 clinics in central Mozambique using routine patient data and monthly reports. Patients referred from voluntary counseling and testing (VCT) were compared with those referred from prevention of mother-to-child transmission (PMTCT) for 3 outcomes: (1) enrollment at an HIV clinic ≤30 days after testing HIV positive, (2) CD4 test ≤30 days after enrollment, and (3) ART initiation ≤90 days after first CD4 test., Results: Patient retention in the HIV care system dropped at each step from HIV testing to ART initiation. Enrollment in HIV care was not significantly different between PMTCT and VCT [risk ratio (RR) = 0.84, 0.72 < RR < 1.02]. Women tested in PMTCT were less likely to have a CD4 test ≤30 days after enrollment when adjusting for age, education level, and marital status (adjusted RR = 0.84, 0.70 < RR < 1.00), and were less likely to initiate ART ≤90 days after their first CD4 test when adjusting for age, education, and marital status (adjusted RR = 0.56, 0.44 < RR < 0.71)., Conclusions: Poor linkages between HIV testing and care hamper efforts to improve coverage for HIV care and treatment services. Increased loss to follow-up among women diagnosed in PMTCT relative to VCT is worrisome and merits further qualitative research and programmatic attention.

Among infants exposed to human immunodeficiency virus type 1 (HIV-1), detection of viral infection at birth was increased by 39% (95% confidence interval, 19%-47%) by increasing DNA input from dried blood spots into polymerase chain reaction. Infants with low concentrations of HIV-1 at birth may be the best target population to evaluate whether immediate antiretroviral therapy can prevent long-term infection.

Background: In 2004, the Mozambican Ministry of Health began a national scale-up of antiretroviral therapy (ART) using a vertical model of HIV clinics colocated within large urban hospitals. In 2006, the ministry expanded access by integrating ART into primary health care clinics., Methods: We conducted a retrospective cohort study including adult ART-naive patients initiating ART between January 2006 and June 2008 in public sector clinics in Manica and Sofala provinces. Cox proportional hazards models with robust variances were used to estimate the association between clinic model (vertical/integrated), clinic location (urban/rural), and clinic experience (first 6 months/post first 6 months) and attrition occurring in early patient follow-up (≤ 6 months) and attrition occurring in late patient follow-up (>6 months), while controlling for age, sex, education, pre-ART CD4 count, World Health Organization stage and pharmacy staff burden., Results: A total of 11,775 patients from 17 clinics were studied. The overall attrition rate was 37 per 100 person-years. Patients attending integrated clinics had a higher risk of attrition in late follow-up [hazard ratio (HR) = 1.75; 95% confidence interval (CI): 1.04 to 2.94], and patients attending urban clinics (HR = 0.57; 95% CI: 0.35 to 0.91) had a lower risk of attrition in late follow-up. Though not statistically significant, clinics open for longer than 6 months (HR = 0.71; 95% CI: 0.49 to 1.04) had a lower risk of attrition in early follow-up., Conclusions: Patients attending vertical clinics had a lower risk of attrition. Utilizing primary health clinics to implement ART is necessary to reach higher levels of coverage; however, further implementation strategies should be developed to improve patient retention in these settings.

Single-dose nevirapine (sdNVP) given to prevent mother-to-child-transmission of HIV-1 selects NVP-resistance. Short-course zidovudine (ZDV) was hypothesized to lower rates of NVP-resistance. HIV-1 infected pregnant women administered sdNVP with or without short-course ZDV were assessed for HIV-1 mutations (K103N, Y181C, G190A, and V106M) prior to delivery and postpartum. Postpartum NVP-resistance was lower among 31 taking ZDV+sdNVP compared to 33 taking only sdNVP (35.5% vs. 72.7%; χ2 P = .003). NVP mutants decayed to <2% in 24/35 (68.6%) at a median 6 months postpartum, with no differences based on ZDV use (logrank P = .99). Short-course ZDV was associated with reduced NVP-resistance mutations among women taking sdNVP.

Background: Since the rapid scale-up of antiretroviral therapy (ART) programs in sub-Saharan Africa, electronic patient tracking systems (EPTS) have been deployed to respond to the growing demand for program monitoring, evaluation and reporting to governments and donors. These routinely collected data are often used in epidemiologic and operations research studies intended to improve programs. To ensure accurate reporting and good quality for research, the reliability and completeness of data systems need to be assessed and reported. We assessed the completeness and reliability of EPTS used in 16 HIV care and treatment clinics in Manica and Sofala provinces of Mozambique., Methods: We conducted a cross-sectional study to assess the completeness and reliability of key variables in the electronic data system for patients enrolling in 16 public sector HIV treatment clinics between 1 July 2004 and 30 June 2008. Data from the electronic database was compared with data abstracted from a stratified random sample of 520 patient charts. Percent agreement, kappa scores and concordance correlation coefficients were calculated for specified variables. Percentile bootstrap confidence intervals were calculated to account for the stratified nature of our sampling., Results: A total of 16,149 patients with a median age of 33 years and a median CD4 count of 151 enrolled in these 16 clinics between 1 July 2004 and 30 June 2008. The level of completeness was high for most variables with height (18.6%) and weight (11.5%) having the highest amount of missing data. The level of agreement for available data was also high with reliability statistics of 0.95 (95% CI: 0.92-0.98) for gender, 0.91 (95% CI: 0.80-1.00) for pre-ART CD4 value and 0.97 (95% CI: 0.95-0.99) for patient retention., Conclusions: Electronic patient tracking systems have been deployed to respond to the growing monitoring, evaluation and reporting requirements. In our cross-sectional study of clinics in Manica and Sofala provinces of Mozambique, we found high levels of completeness and reliability for key variables indicating that these electronic databases provided adequate data not only for monitoring and evaluation but also for research. Routine evaluations of the completeness and reliability of these databases need to occur to ensure high quality data are being used for reporting and research.

Introduction: Human resource shortages are viewed as one of the primary obstacles to provide effective services to growing patient populations receiving antiretroviral therapy (ART) and to expand ART access further. We examined the relationship of patient volume, human resource levels, and patient characteristics with attrition from HIV treatment programs in central Mozambique., Methods: We conducted a retrospective cohort study of adult, ART-naive, nonpregnant patients who initiated ART between January 2006 and June 2008 in the national HIV care program. Cox proportional hazards models were used to assess the association of patient volume, clinical staff burden, and pharmacy staff burden with attrition, adjusting for patient characteristics., Results: A total of 11,793 patients from 18 clinics were studied. After adjusting for patient characteristics, patients attending clinics with medium pharmacy staff burden [hazard ratio (HR) = 1.39 (95% CI: 1.07 to 1.80)] and high pharmacy staff burden [HR = 2.09 (95% CI: 1.50 to 2.91)] tended to have a higher risk of attrition (P value for trend: <0.001). Patients attending clinics with higher clinical staff burden did not have a statistically higher risk of attrition. Patients attending clinics with medium patient volume levels [HR = 1.45 (95% CI: 1.04 to 2.04)] and high patient volume levels [HR = 1.41 (95% CI: 1.04 to 1.92)] had a higher risk of attrition, but the trend test was not significant (P = 0.198)., Discussion: Patients attending clinics with higher pharmacy staff burden had a higher risk of attrition. These results highlight a potential area within the health system where interventions could be applied to improve the retention of these patient populations.

We assessed sexual behaviors before and 12-months after ART initiation among 277 Mozambicans attending an HIV clinic. Measured behaviors included the number of sexual partners, condom use, concurrent relationships, disclosure of HIV status, alcohol use, and partners' serostatus. Compared to before ART initiation, increases were seen 12 months after ART in the proportion of participants who were sexually active (48% vs. 64% respondents, P < 0.001) and the proportion of participants with HIV-negative or unknown serostatus partners (45% vs. 80%, P < 0.001). Almost all (96%) concurrent partnerships reported at 12 months formed after ART initiation. Although reported correct and consist condom use increased, the number of unprotected sexual relationships remained the same (n = 45). Non-disclosure of HIV-serostatus to sexual partners was the only significant predictor of practicing unprotected sex with partners of HIV-negative or unknown serostatus. Sexual activity among HIV-positive persons on ART increased 12 months after ART initiation. Ongoing secondary transmission prevention programs addressing sexual activity with multiple partners, disclosure to partners and consistent condom use with serodisconcordant partners must be incorporated throughout HIV care programs.

Background: In women, single-dose nevirapine for prophylaxis against mother-to-child transmission of human immunodeficiency virus type 1 (HIV-1) selects for nevirapine-resistant HIV-1, which subsequently decays rapidly. We hypothesized that the selection, acquisition, and decay of nevirapine-resistant HIV-1 differs in infants, varying by the timing of HIV-1 infection., Methods: We conducted a prospective, observational study of 740 Mozambican infants receiving single-dose nevirapine prophylaxis and determined the timing of infection and concentrations of nevirapine-resistant HIV-1 over time., Results: Infants with established in utero infection had a high rate (87.0%) of selection of nevirapine-resistant HIV-1 mutants, which rapidly decayed to undetectable levels. The few without nevirapine resistance received zidovudine with single-dose nevirapine and/or their mothers took alternative antiretroviral drugs. Infants with acute in utero infection had a lower rate of nevirapine-resistant HIV-1 (33.3%; P = .006, compared with established in utero infection), but mutants persisted over time. Infants with peripartum infection also had a lower rate of nevirapine-resistant HIV-1 (38.1%; P = .001, compared with established in utero infection) but often acquired 100% mutant virus that persisted over time (P = .017, compared with established in utero infection)., Conclusions: The detection and persistence of nevirapine-resistant HIV-1 in infants after single-dose nevirapine therapy vary by the timing of infection and the antiretroviral regimen. In infants with persistent high-level nevirapine-resistant HIV-1, nevirapine-based antiretroviral therapy is unlikely to ever be efficacious because of concentrations in long-lived viral reservoirs. However, the absence or decay of nevirapine-resistant HIV-1 in many infants suggests that nevirapine antiretroviral therapy may be effective if testing can identify these individuals.

Introduction: In 2004, Mozambique, supported by large increases in international disease-specific funding, initiated a national rapid scale-up of antiretroviral treatment (ART) and HIV care through a vertical "Day Hospital" approach. Though this model showed substantial increases in people receiving treatment, it diverted scarce resources away from the primary health care (PHC) system. In 2005, the Ministry of Health (MOH) began an effort to use HIV/AIDS treatment and care resources as a means to strengthen their PHC system. The MOH worked closely with a number of NGOs to integrate HIV programs more effectively into existing public-sector PHC services., Case Description: In 2005, the Ministry of Health and Health Alliance International initiated an effort in two provinces to integrate ART into the existing primary health care system through health units distributed across 23 districts. Integration included: a) placing ART services in existing units; b) retraining existing workers; c) strengthening laboratories, testing, and referral linkages; e) expanding testing in TB wards; f) integrating HIV and antenatal services; and g) improving district-level management., Discussion: By 2008, treatment was available in nearly 67 health facilities in 23 districts. Nearly 30,000 adults were on ART. Over 80,000 enrolled in the HIV/AIDS program. Loss to follow-up from antenatal and TB testing to ART services has declined from 70% to less than 10% in many integrated sites. Average time from HIV testing to ART initiation is significantly faster and adherence to ART is better in smaller peripheral clinics than in vertical day hospitals. Integration has also improved other non-HIV aspects of primary health care., Conclusion: The integration approach enables the public sector PHC system to test more patients for HIV, place more patients on ART more quickly and efficiently, reduce loss-to-follow-up, and achieve greater geographic HIV care coverage compared to the vertical model. Through the integration process, HIV resources have been used to rehabilitate PHC infrastructure (including laboratories and pharmacies), strengthen supervision, fill workforce gaps, and improve patient flow between services and facilities in ways that can benefit all programs. Using aid resources to integrate and better link HIV care with existing services can strengthen wider PHC systems.

Objectives: To compare HIV care quality provided by non-physician clinicians (NPC) and physicians., Design: Retrospective cohort study assessing the relationship between provider cadre and HIV care quality among non-pregnant adult patients initiating antiretroviral therapy (ART) in the national HIV care programme., Methods: Computerized medical records from patients initiating ART between July 2004 and October 2007 at two HIV public HIV clinics in central Mozambique were used to develop multivariate analyses evaluating differences in process and care continuity measures for patients whose initial provider was a NPC or physician., Results: A total of 5892 patients was included in the study, including 4093 (69.5%) with NPC and 1799 (30.5%) with physicians as initial providers. Those whose initial provider was a NPC were more likely to have a CD4 cell count 90-210 days [risk ratio (RR) 1.13, 1.04

The shortage of health workers impedes universal coverage of quality HIV services, especially in those countries hardest hit by the epidemic. The dramatic increase in international aid to scale-up HIV services, including antiretroviral therapy (ART), has highlighted workforce deficiencies and provided an opportunity to strengthen health systems capacity. In Mozambique, a country with a high HIV burden and a staggering workforce deficit, the Ministry of Health looked to past experience in workforce expansion to rapidly build ART delivery capacity, including reliance on existing nonphysician clinicians (NPC) to prescribe ART and dramatically increasing the output of NPC training. As a result of responsible task shifting, the number of facilities providing ART tripled during a 6-month period, and patients from disadvantaged areas have access to quality ART services. Because the NPC-driven ART approach is integrated into primary health care, the addition of new clinical staff also promises to improve general health services.

Introduction: Access to antiretroviral treatment (ART) has expanded dramatically in resource-limited settings. Evaluating loss to follow-up from HIV testing through post-ART care can help identify obstacles to care., Methods: Routine data were analyzed for adults receiving services in 2 public HIV care systems in central Mozambique. The proportion of people passing through the following steps was determined: (1) HIV testing, (2) enrollment at an ART clinic, (3) CD4 testing, (4) starting ART if eligible, and (5) adhering to ART., Results: During the 12-month study period (2004-2005), an estimated 23,430 adults were tested for HIV and 7005 (29.9%) were HIV positive. Only 3956 (56.5%) of those HIV positive enrolled at an ART clinic < or =30 days after testing. CD4 testing was obtained in 77.1% < or =30 days of enrollment. Of 1506 eligible for ART, 471 (31.3%) started ART < or =90 days after CD4 testing. Of 382 with > or =180 days of potential follow-up time on ART, 317 (83.0%) had pharmacy-based adherence rates > or =90%., Discussion: Substantial drop-offs were observed for each step between HIV testing and treatment but were highest for referral from HIV testing to treatment sites and for starting ART. Interventions are needed to improve follow-up and ensure that people benefit from available HIV services.

Objective: To assess the efficacy of a peer-delivered intervention to promote short-term (6-month) and long-term (12-month) adherence to HAART in a Mozambican clinic population., Design: A 2-arm randomized controlled trial was conducted between October 2004 and June 2006., Participants: Of 350 men and women (> or = 18 years) initiating HAART, 53.7% were female, and 97% were on 1 fixed-dose combination pill twice a day., Intervention: Participants were randomly assigned to receive 6 weeks (Monday through Friday; 30 daily visits) of peer-delivered, modified directly observed therapy (mDOT) or standard care. Peers provided education about treatment and adherence and sought to identify and mitigate adherence barriers., Outcome: Participants' self-reported medication adherence was assessed 6 months and 12 months after starting HAART. Adherence was defined as the proportion of prescribed doses taken over the previous 7 days. Statistical analyses were performed using intention-to-treat (missing = failure)., Results: Intervention participants, compared to those in standard care, showed significantly higher mean medication adherence at 6 months (92.7% vs. 84.9%, difference 7.8, 95% confidence interval [CI]: 0.0.02, 13.0) and 12 months (94.4% vs. 87.7%, difference 6.8, 95% CI: 0.9, 12.9). There were no between-arm differences in chart-abstracted CD4 counts., Conclusions: A peer-delivered mDOT program may be an effective strategy to promote long-term adherence among persons initiating HAART in resource-poor settings.

As resource-limited countries expand access to highly active antiretroviral therapy (HAART) treatment, innovative programs are needed to support adherence in the context of significant health system barriers. Modified directly observed therapy (mDOT) is one such strategy, but little is known about the process of designing and implementing mDOT programs for HAART in resource-limited settings. In this descriptive study, we used a mixed-methods approach to describe the process of implementing mDOT for an ongoing randomized control trial (RCT) in Beira, Mozambique. Interviews with clinic staff, mDOT peers, and participants provided information on design elements, problems with implementation, satisfaction, and benefits. Acceptability and feasibility measures were obtained from the RCT. Most (81%, N = 350) eligible persons agreed to participate, and of those randomized to mDOT (n = 174), 95% reported that their time with peers was beneficial. On average, participants kept 93% of the 30 required daily mDOT visits. Key components of the intervention's success included using peers who were well accepted by clinic staff, adequate training and retention of peers, adapting daily visit requirements to participants' work schedules and physical conditions, and reimbursing costs of transportation. This study identified aspects of mDOT that are effective and can be adopted by other clinics treating HIV patients.

Approximately one million pregnancies are complicated by both malaria and HIV infection in sub-Saharan Africa annually. Both infections have been associated with maternal and infant morbidity and mortality. Intermittent preventive treatment, usually with sulfadoxine-pyrimethamine, has been shown to prevent pregnancy-related malaria and its complications. Several different regimens of antiretroviral therapy are now available to prevent mother-to-child transmission of HIV and/or progression of maternal HIV infection during pregnancy. However, no published studies have yet shown whether standard intermittent preventive treatment and antiretroviral regimens are medically and operationally compatible in pregnancy. We reviewed existing policies regarding prevention and treatment of HIV and malaria in pregnancy, as well as published literature on adverse effects of antiretrovirals and antimalarials commonly used in pregnancy in developing countries, and found that concurrent prescription of sulfadoxine-pyrimethamine, co-trimoxazole (trimethoprim-sulfamethoxazole), and antiretroviral agents including nevirapine and zidovudine per existing protocols for prevention of malaria and vertical HIV transmission may result in adverse drug interactions or overlapping, diagnostically challenging drug toxicities. Insecticide-treated bednets should be provided for HIV-infected pregnant women at risk for malaria. Sulfadoxine-pyrimethamine should be prescribed cautiously in women concurrently receiving daily nevirapine and/or zidovudine, and should be avoided in women on daily co-trimoxazole. Further research is urgently needed to define safe and effective protocols for concurrent management of HIV and malaria in pregnancy, and to define appropriate interventions for different populations subject to differing levels of malaria transmission and antimalarial drug resistance.