In Their Own Voices: Vulnerabilities & Abilities of Women & Families in Health Research on the Thai-Myanmar border
- Conditions
- Malaria, Hepatitis B infected, Vulnerable conditionVulnerableEmpowermentAdvocacyEthicsPublic engagement
- Registration Number
- TCTR20180921001
- Lead Sponsor
- niversity of Oxford
- Brief Summary
This research confirms that research is important, to inform evidence-based medical care in LMICs settings. Moreover, we found that migrants living along the Thai-Myanmar border, which they were traditionally deemed vulnerable, do exercise their agency and resourcefulness when they navigate through their daily challenges, and at the same time, they have the ability to understand benefits and risks and able to make decision to participate in important health research.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
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
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)