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NCT ID: NCT02744586 Completed - HIV Clinical Trials

Zambia One Love Aim 3 Trial

Start date: January 2016
Phase: N/A
Study type: Interventional

The aim of this study is to determine whether a Strengthening our Vows (SOV) intervention will reduce HIV exposures from concurrent partnership (CP) when compared to the control Good Health Package Plus (GHPP), in addition to couples' voluntary HIV counseling and testing (CVCT), among concordant HIV-negative couples living in Zambia.

NCT ID: NCT02729532 Completed - Tuberculosis Clinical Trials

Effect of Xpert MTB/RIF on Patient Outcomes

Start date: June 22, 2016
Phase:
Study type: Observational

A parallel-group prospective cohort study among adult persons living with HIV/AIDS to study the effect of a new TB diagnostic test, Xpert MTB/RIF on: 1) TB case detection; 2) time to TB diagnosis and TB treatment; 3) presumptive TB patient drop-out from the TB diagnostic "cascade" before starting TB treatment; and 4) loss to follow-up after initiation of TB treatment.

NCT ID: NCT02709967 Completed - Clinical trials for Pregnancy in Adolescence

Research Initiative to Support the Empowerment of Girls

RISE
Start date: March 4, 2016
Phase: N/A
Study type: Interventional

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).

NCT ID: NCT02700269 Completed - Malaria Diagnosis Clinical Trials

Vanderbilt-Zambia Innovations in Global Health Technologies

VZNIGHT
Start date: April 2016
Phase:
Study type: Observational

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.

NCT ID: NCT02688816 Completed - Cervical Cancer Clinical Trials

Comparison of Cervical Cancer Screening Tests in HIV-infected Women in Lusaka, Zambia

Start date: August 2014
Phase: N/A
Study type: Observational

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

NCT ID: NCT02682810 Completed - Clinical trials for Early Infant HIV Diagnosis

Point of Care Virologic Testing to Improve Outcomes of HIV-Infected Children

Start date: February 2016
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT02661763 Completed - Clinical trials for Rheumatic Heart Disease

Rheumatic Heart Disease Study in Lusaka

Start date: September 2015
Phase: N/A
Study type: Observational

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.

NCT ID: NCT02654912 Completed - Malaria Clinical Trials

Community-led Responses for Elimination: Controlled Trial of Reactive Case Detection Versus Reactive Drug Administration

CORE Zambia
Start date: February 2016
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT02620436 Completed - Maternal Health Clinical Trials

Impact Evaluation of Maternity Homes Access in Zambia

MAHMAZ
Start date: March 2016
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT02612896 Completed - Clinical trials for Taenia Solium Infection

Taenia Solium Elimination Versus Control: What is the Best Way Forward for Sub-Saharan Africa?

CYSTISTOP
Start date: March 2016
Phase: N/A
Study type: Interventional

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.