There are about 292 clinical studies being (or have been) conducted in Zambia. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Background Adolescent pregnancies carry risks to the young mothers and the babies. Keeping girls in school can potentially protect girls from getting pregnant. In Zambia, 35% of young rural girls have given birth by the age of 18 years, and the pregnancy rates are particularly high among girls who are out-of-school. Approximately 50% of girls never enroll in secondary school. Widespread myths and negative social norms are barriers to adolescent girls using modern contraceptives, thus contributing to high rates of early pregnancy. However, there is little robust research from Africa on how sexual and reproductive health programmes can be delivered in a way that actually affects early marriage and pregnancy rates. Purpose To measure the effect on early childbearing rates and basic school completion in a rural Zambian context of (1) economic support to girls and their families, and (2) combining economic support with a community intervention to enhance knowledge about sexual and reproductive health and supportive community norms Design Cluster randomized controlled trial with three arms with clusters being rural basic schools (With grades 1-9) with surrounding communities. Study population The participant population were girls enrolled in grade 7 in January in 2016 in rural schools in twelve study districts: Kalomo, Choma, Pemba, Monze, Mazabuka, Chikankata, Kapiri Mposhi, Kabwe, Chisamba, Chibombo, Mkushi, and Luano. Study size A total of 4922 girls and 157 clusters were recruited, that is 999 girls and 31 clusters in the control arm and 2004 and 63 clusters in the economic support arm and 1919 girls and 63 schools in the combined intervention arms. The rationale for having different numbers of clusters was that we expected larger differences between each of the intervention arms and the control arm than between the two intervention arms themselves. Intervention One intervention arm was offered economic support in the form of monthly cash transfers to the participating girl and her parents and payment of junior secondary school fees in 2017 and 2018. The second intervention arm was offered the same economic support combined with a community component comprising community meetings about the value of education for adolescent girls and the risks related to early childbearing, and a youth club covering comprehensive sexuality education for girls and boys (both in- and out-of-school).
Investigators will evaluate approaches using magnetic bead capture, isolation, and surface tension valve transfer of biomarkers to process capillary blood in order to improve the sensitivity of already approved Rapid Diagnostic Tests (RDTs) for detection of human malaria infection. Results will be compared to those obtained using unenhanced capillary blood specimens directly applied to approved malaria RDTs. Participants seeking care for possible malaria in Zambia will be recruited to enroll in the study.
This study will compare the test performance characteristics of visual inspection with acetic acid (VIA), Xpert HPV, and OncoE6 in HIV-infected women, to inform the possible inclusion of these molecular tests in future cervical cancer screening
This is a two-arm, unmasked, randomized, controlled trial to test the effectiveness of the Alere Q point-of-care (POC) HIV diagnostic assay for use in resource-poor settings.
This study will determine the prevalence of rheumatic heart disease (RHD) in Lusaka, Zambia through school-based screening methodology using ultraportable echocardiography and a recently validated, abridged screening protocol based on World Heart Federation criteria. Children that screen positive for RHD at schools will undergo confirmatory evaluation at University Teaching Hospital (UTH), Lusaka's main referral hospital.
This study is designed to compare the effectiveness of reactive focal drug administration (RFDA) using dihydroartemisinin+piperaquine (DHAP) versus reactive focal test and treat (RFTAT) using artemether+lumefantrine (AL) as a routine process for identifying and eliminating malaria transmission as measured through achieving zero seropositivity in children under five in Southern Province, Zambia. These two strategies are potential candidates for expanded malaria operational surveillance and elimination for low malaria transmission areas.
Objectives: The primary objective of this evaluation is to determine if well-constructed and well-resourced Maternity Waiting Homes are utilized by pregnant women living at distance from the health facility and are associated with improved pregnancy outcomes, particularly for women living farthest from health facilities. Findings from this evaluation will be provided to policymakers formulating policy decisions affecting the implementation of the Maternity Home Model and, if applicable, will be used as evidence for programmatic decisions made by the Ministry in deciding to take this model to scale beyond the districts proposed for this project. Primary Impact Evaluation Question: Does the Minimum Core Maternity Home Model increase access to high quality intrapartum care among mothers living more than 10 km from the facilities compared to the standard of care? Study Design: We propose a quasi-experimental pre-post design wherein one implementing partner (BU/ZCAHRD) will use a cluster-randomized matched pair design and one implementing partner (University of Michigan/Africare) will utilize a matched-pair, two-group comparison design with no randomization. Methods: Using mixed-methods, we will collect data from two main sources: 1) Household Surveys and 2) In-depth Interviews. A quantitative household survey will be conducted among 2,400 randomly-selected households at both baseline (2015) and endline (2018) among recently delivered women (delivered in the last 12 months) living more than 10 km from the intervention and comparison facilities. 15% of the households enrolled in the study will be randomly selected to participate in an In-Depth Interview (IDI). Content will include perceptions of labor and delivery practices, barriers to accessing care, knowledge and awareness of MSs, perceptions of the quality of MS, perceptions of respectful care at the facility, post-natal care, costs, and perceptions of MS ownership.
Taenia solium taeniosis/cysticercosis is a neglected zoonotic parasitic disease complex with significant economic and public health impacts, occurring primarily in developing countries. Humans are the carriers of the tapeworm (taeniosis); the normal intermediate pig host develops the metacestode larval stage (porcine cysticercosis). However, people can also act as accidental intermediate hosts and develop human cysticercosis or neurocysticercosis (NCC) when the central nervous system is involved. The scattered efforts of researchers into evaluation of control programmes in Sub-Saharan Africa (SSA) have focussed on single control options. It is becoming clear that these stand-alone options have the potential to reduce the occurrence of the parasite, however either long term or more integrated efforts seem to be required to reach an elimination status. The objective of the current study is to evaluate the cost-effectiveness/acceptability of elimination (to be achieved on a short term via integrated measures), and control (single measures, with an elimination goal on a longer term) of T. solium in a highly endemic area in SSA. This intervention study will entail an elimination study arm in which multiple control options are combined (integrated) aiming at the final human host (Mass drug administration (MDA) and health education) and pig intermediate hosts (pig treatment and vaccination). In a second study arm a single control option will be carried out (pig treatment). In both study arms (health) education will be implemented. At baseline and in the final sampling year, prevalence of human taeniosis/cysticercosis and porcine cysticercosis will be determined in all study villages. Active ongoing surveillance and 6 monthly (biannual) human and pig sampling will be conducted in the elimination study arm, as well as two-yearly (biennial) sampling of the pig intermediate host in the control study arm. Additionally, (open ended) questionnaires and focus group discussions will be administered/held to obtain data on the cost of pig keeping, T. solium, the interventions and the perception/acceptability of the proposed control measures to the local communities.
Participants will receive vaccination for measles, mumps, and rubella (MMR) and tetanus, diphtheria, pertussis, and inactivated polio (Tdap-IPV). The study schedule design is to simulate a vaccine efficacy trial to see if single women can participate in studies that mimic actual HIV vaccine studies.
Diagnosis of tuberculosis (TB)in young children is a challenge due to atypical non-specific symptoms, difficulty to expectorate mucus, paucibacillary nature of pulmonary TB and low sensitivity of available diagnostic tools. This project aims at evaluating two innovative immunological methods for diagnosing of active TB among HIV-infected and uninfected children.