Malaria, Hepatitis B infected, Vulnerable condition Vulnerable Empowerment Advocacy Ethics Public engagement
Conditions
Interventions
Group 1a. Pregnant women or women who were pregnant when they first participated in DMA or TDF studies (as details below) and
Group 1b. their husbands/partners their family members or key supporters
OXTREC ref. 49-16
CMU REC-2591010-8121
JHU IRB00007432 and FTM EC (TMEC 17-017)
,Researchers, study administrators/coordinators and frontline healthcare workers who have been involved in above studies, members of the Tak Province Community
Other,Other,Other
Pregnant women or women who were pregnant, or their husbands/partners, or key supporters,Researchers, study administrators/coordinators and frontline healthcare workers ,Key representatives in communi
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Participants will be male or female, aged 18 years and above, who have provided written informed consent, and who belong to one of the following three groups: (1) Group 1. 1a. Pregnant women or women who were pregnant when they first participated in DMA or TDF studies and 1b. their husbands/partners, their family members and/or key supporters. REACH study team will recruit group 1a participants from DMA and TDF studies, thus follow the inclusion and exclusion criteria of the two projects which are listed below: DMA study Inclusion criteria 1. Age 18-45 years old 2. Gestational age (ultrasound confirmed) more than 13.0 weeks 3. Viable fetus as assessed by ultrasound scanning 4. Microscopically confirmed uncomplicated malaria (parasitaemia more than or equal to 5/500 WBC) with Plasmodium falciparum or Mixed infection (i.e. P. falciparum & P.vivax/ovale/malariae) or Plasmodium vivax/ovale/malariae 5. Willingness and ability to comply with the study protocol for the duration of the trial 6. Written informed consent provided 7. No signs of labour Additional criteria for patients in the detailed pharmacokinetic study group (N as 24 in the MAS3 arm): 1. HCT more than 25% (based on filed reading i.e. capillary sample) 2. P. falciparum monoinfection 3. Agree to stay in the clinic for 7 days 4. Written consent to participate in the detailed pharmacokinetic subgroup Exclusion criteria 1. Know hypersensitivity to the study drugs 2. P. falciparum asexual stage parasitaemia more than or equal to 4% RBCs 3. Clinical or laboratory features of severe malaria based on WHO criteria-Appendix 1 4. Gastrointestinal dysfunction that could alter absorption or motility 5. History or known liver diseases or other chronic diseases (excluding thalassemia & G6PD deficiency) 6. Presence of intercurrent illness or any condition which in the judgement of the investigator would place the patient at undue risk or interfere with the results of the study 7. Splenectomy 8. Hematocrit (HCT) less than 20% (based on field reading i.e. capillary sample) (NB: Dense mefloquine pharmacokinetic exclusion if HCT less than 25%) 9. Taking contraindicated medications 10. History of narcotic of alcohol abuse TDF study Inclusion Criteria All of the inclusion criteria must be answered as yes to consider the participant eligible: 1. The woman is willing and able to give informed consent for participation in the study. 2. Hepatitis B infected (HBsAg confirmed positive) 3. Female, 16-49 years (inclusive). 4. Estimated gestational age of 12-20 weeks at time TDF is started. 5. Willing to take TDF daily during pregnancy. 6. Plans to deliver at SMRU. 7. Able (in the Investigators opinion) and willing to comply with all study requirements Exclusion Criteria If any exclusion criteria are answered as yes the participant may not enter the study: 1. HIV positive or on immunosuppressive therapy for other illnesses 2. elevated creatinine (more than 1 mg/dL) 3. abnormal serum phosphate (less than 2.4 and more than 4.5 mg/dL) 4. history of kidney disease 5. History of pregnancy complications, short cervix DMA and TDF participants are a mixture of Karen and Burmese speaking groups. Additionally, all of the visitors to all SMRU clinics who are from different ethnic groups and living as cross-border migrants often speak one of these two language
Exclusion criteria
Exclusion criteria: -
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A context-sensitive ethical account 3 years from date of ethics approval In-depth interviews (IDIs) and focus group discussion (FGDs),Framework of the specific vulnerabilities 3 years from date of ethics approval In-depth interviews (IDIs) and focus group discussion (FGDs),Sources of support/empowerment 3 years from date of ethics approval In-depth interviews (IDIs) and focus group discussion (FGDs) | — |
Secondary
| Measure | Time frame |
|---|---|
| A map of key points of how potential vulnerabilities-abilities are identified 3 years from date of ethics approval In-depth interviews (IDIs) and focus group discussion (FGDs),An account of how to respond to participant vulnerabilities and leverage support/empowerment 3 years from date of ethics approval In-depth interviews (IDIs) and focus group discussion (FGDs),An account of how to respond to ethical challenges related to vulnerabilities of participants 3 years from date of ethics approval In-depth interviews (IDIs) and focus group discussion (FGDs) | — |
Countries
Thailand
Contacts
Public ContactPhaikyeong Cheah
Oxford University
Outcome results
None listed