- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02667808
Exploring the Impact of HIV and ART on Knowledge, Attitudes and Practices in Reproductive Health in Lilongwe, Malawi (HIV KAP)
Study Overview
Status
Intervention / Treatment
Detailed Description
The aim of this study is to identify reproductive health priorities among individuals living with HIV.This study also seeks to explore factors that influence fertility, family planning, and sexual behavior among individuals with HIV who are receiving antiretroviral therapy (ART).
This is a mixed method study in which subjects will participate in focused group discussions and complete a questionnaire. Discussions will be 1-2 hours in length aimed to evaluate fertility intentions, family planning, and sexual health behaviors. Data collected from the focus groups will be analyzed for common themes to generate questionnaires to assess reproductive health knowledge, attitudes and practices related to family planning, and fertility and sexual health among persons living with HIV.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Lilongwe, Malawi
- The Lighthouse Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Focus Group Arm
Inclusion Criteria:
- Client registered at either of the participating Lighthouse clinics (Kamuzu Central Hospital (KCH) or Bwaila Hospital)
- On antiretroviral treatment (ART) for the past 6 months
- Sexually active within the past 6 months
- HIV positive
Exclusion Criteria:
No exclusion criteria specified
Questionnaire Arm
Inclusion Criteria:
- Client registered at either of the participating Lighthouse clinics (Kamuzu Central Hospital (KCH) or Bwaila Hospital)
- Sexually active within the past 6 month
- HIV positive
Exclusion Criteria:
No exclusion criteria specified
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Focus Group
Participants with HIV and receiving antiretroviral therapy (ART) will participate in four to eight group discussions aimed to evaluate fertility intentions, family planning, and sexual health behaviors.
Discussions will be 1-2 hours in length.
Groups will be conducted among men and women.
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Subjects will participate in four to eight group discussions aimed to evaluate fertility intentions, family planning, and sexual health behaviors.
Discussions will be 1-2 hours in length.
Groups will be conducted among men and women.
|
Questionnaire
Participants with HIV will complete a questionnaire assessing reproductive health knowledge, attitudes and practices related to family planning, and fertility and sexual health.
The questionnaire will take no longer than 30 minutes to complete.
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Participants will complete a questionnaire assessing reproductive health knowledge, attitudes and practices related to family planning, and fertility and sexual health.
The questionnaire will take no longer than 30 minutes to complete.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perception of ideal family size assessed by focus group discussion
Time Frame: Discussion Visit (Day 0, Up to 2 hours)
|
Perception of ideal family size will be discussed in a focus group setting between 6-8 men or women.
Focus groups will be facilitated by a trained member of the research team.
The discussions will be audio taped and there will be a note-taker attending each group.
Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication.
Focus group discussion will take between one to two hours.
|
Discussion Visit (Day 0, Up to 2 hours)
|
Perception of social pressures regarding fertility intentions assessed by focus group discussion
Time Frame: Discussion Visit (Day 0, Up to 2 hours)
|
Perception of social pressures regarding fertility intentions will be discussed in a focus group setting between 6-8 men or women.
Focus groups will be facilitated by a trained member of the research team.
The discussions will be audio taped and there will be a note-taker attending each group.
Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication.
Focus group discussion will take between one to two hours.
|
Discussion Visit (Day 0, Up to 2 hours)
|
Perception of familial pressures regarding fertility intentions assessed by focus group discussion
Time Frame: Discussion Visit (Day 0, Up to 2 hours)
|
Perception of familial pressures regarding fertility intentions will be discussed in a focus group setting between 6-8 men or women.
Focus groups will be facilitated by a trained member of the research team.
The discussions will be audio taped and there will be a note-taker attending each group.
Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication.
Focus group discussion will take between one to two hours.
|
Discussion Visit (Day 0, Up to 2 hours)
|
Perception of partner pressures regarding fertility intentions assessed by focus group discussion
Time Frame: Discussion Visit (Day 0, Up to 2 hours)
|
Perception of partner pressures regarding fertility intentions will be discussed in a focus group setting between 6-8 men or women.
Focus groups will be facilitated by a trained member of the research team.
The discussions will be audio taped and there will be a note-taker attending each group.
Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication.
Focus group discussion will take between one to two hours.
|
Discussion Visit (Day 0, Up to 2 hours)
|
Influence of human immunodeficiency virus (HIV) on fertility intentions assessed by focus group discussion
Time Frame: Discussion Visit (Day 0, Up to 2 hours)
|
Influence of human immunodeficiency virus (HIV) on fertility intentions will be discussed in a focus group setting between 6-8 men or women.
Focus groups will be facilitated by a trained member of the research team.
The discussions will be audio taped and there will be a note-taker attending each group.
Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication.
Focus group discussion will take between one to two hours.
|
Discussion Visit (Day 0, Up to 2 hours)
|
Influence of antiretroviral therapy (ART) on fertility intentions assessed by focus group discussion
Time Frame: Discussion Visit (Day 0, Up to 2 hours)
|
Influence of antiretroviral therapy (ART) on fertility intentions will be discussed in a focus group setting between 6-8 men or women.
Focus groups will be facilitated by a trained member of the research team.
The discussions will be audio taped and there will be a note-taker attending each group.
Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication.
Focus group discussion will take between one to two hours.
|
Discussion Visit (Day 0, Up to 2 hours)
|
Perception of concordance among couples on fertility intention assessed by focus group discussion
Time Frame: Discussion Visit (Day 0, Up to 2 hours)
|
The agreement on fertility intention among couples will be discussed in a focus group setting between 6-8 men or women.
Focus groups will be facilitated by a trained member of the research team.
The discussions will be audio taped and there will be a note-taker attending each group.
Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication.
Focus group discussion will take between one to two hours.
|
Discussion Visit (Day 0, Up to 2 hours)
|
Perception of how relationship status influences fertility intentions assessed by focus group discussion
Time Frame: Discussion Visit (Day 0, Up to 2 hours)
|
The perception of how relationship status influences fertility intentions will be discussed in a focus group setting between 6-8 men or women.
Focus groups will be facilitated by a trained member of the research team.
The discussions will be audio taped and there will be a note-taker attending each group.
Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication.
Focus group discussion will take between one to two hours.
|
Discussion Visit (Day 0, Up to 2 hours)
|
Perception of how reproductive health issues impact fertility intentions assessed by focus group discussion
Time Frame: Discussion Visit (Day 0, Up to 2 hours)
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Perception of how reproductive health issues impact fertility intentions will be discussed in a focus group setting between 6-8 men or women.
Focus groups will be facilitated by a trained member of the research team.
The discussions will be audio taped and there will be a note-taker attending each group.
Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication.
Focus group discussion will take between one to two hours.
|
Discussion Visit (Day 0, Up to 2 hours)
|
Knowledge regarding family planning methods assessed by focus group discussion
Time Frame: Discussion Visit (Day 0, Up to 2 hours)
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Knowledge regarding family planning methods will be discussed in a focus group setting between 6-8 men or women.
Focus groups will be facilitated by a trained member of the research team.
The discussions will be audio taped and there will be a note-taker attending each group.
Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication.
Focus group discussion will take between one to two hours.
|
Discussion Visit (Day 0, Up to 2 hours)
|
Knowledge regarding family planning misconceptions assessed by focus group discussion
Time Frame: Discussion Visit (Day 0, Up to 2 hours)
|
Knowledge regarding family planning misconceptions and beliefs will be discussed in a focus group setting between 6-8 men or women.
Focus groups will be facilitated by a trained member of the research team.
The discussions will be audio taped and there will be a note-taker attending each group.
Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication.
Focus group discussion will take between one to two hours.
|
Discussion Visit (Day 0, Up to 2 hours)
|
Current family planning methods assessed by focus group discussion
Time Frame: Discussion Visit (Day 0, Up to 2 hours)
|
Current family planning methods will be discussed in a focus group setting between 6-8 men or women.
Focus groups will be facilitated by a trained member of the research team.
The discussions will be audio taped and there will be a note-taker attending each group.
Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication.
Focus group discussion will take between one to two hours.
|
Discussion Visit (Day 0, Up to 2 hours)
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Previously used family planning methods assessed by focus group discussion
Time Frame: Discussion Visit (Day 0, Up to 2 hours)
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Previously used family planning methods will be discussed in a focus group setting between 6-8 men or women.
Focus groups will be facilitated by a trained member of the research team.
The discussions will be audio taped and there will be a note-taker attending each group.
Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication.
Focus group discussion will take between one to two hours.
|
Discussion Visit (Day 0, Up to 2 hours)
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Intent to use family planning methods assessed by focus group discussion
Time Frame: Discussion Visit (Day 0, Up to 2 hours)
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Intent to use family planning methods will be discussed in a focus group setting between 6-8 men or women.
Focus groups will be facilitated by a trained member of the research team.
The discussions will be audio taped and there will be a note-taker attending each group.
Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication.
Focus group discussion will take between one to two hours.
|
Discussion Visit (Day 0, Up to 2 hours)
|
Perception of social influence on family planning methods assessed by focus group discussion
Time Frame: Discussion Visit (Day 0, Up to 2 hours)
|
Perception of social influence on family planning methods will be discussed in a focus group setting between 6-8 men or women.
Focus groups will be facilitated by a trained member of the research team.
The discussions will be audio taped and there will be a note-taker attending each group.
Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication.
Focus group discussion will take between one to two hours.
|
Discussion Visit (Day 0, Up to 2 hours)
|
Perception of familial influence on family planning methods assessed by focus group discussion
Time Frame: Discussion Visit (Day 0, Up to 2 hours)
|
Perception of familial influence on family planning methods will be discussed in a focus group setting between 6-8 men or women.
Focus groups will be facilitated by a trained member of the research team.
The discussions will be audio taped and there will be a note-taker attending each group.
Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication.
Focus group discussion will take between one to two hours.
|
Discussion Visit (Day 0, Up to 2 hours)
|
Perception of partner influence on family planning methods assessed by focus group discussion
Time Frame: Discussion Visit (Day 0, Up to 2 hours)
|
Perception of partner influence on family planning methods will be discussed in a focus group setting between 6-8 men or women.
Focus groups will be facilitated by a trained member of the research team.
The discussions will be audio taped and there will be a note-taker attending each group.
Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication.
Focus group discussion will take between one to two hours.
|
Discussion Visit (Day 0, Up to 2 hours)
|
Human immunodeficiency virus (HIV) influence on family planning methods assessed by focus group discussion
Time Frame: Discussion Visit (Day 0, Up to 2 hours)
|
Human immunodeficiency virus (HIV) influence on family planning methods will be discussed in a focus group setting between 6-8 men or women.
Focus groups will be facilitated by a trained member of the research team.
The discussions will be audio taped and there will be a note-taker attending each group.
Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication.
Focus group discussion will take between one to two hours.
|
Discussion Visit (Day 0, Up to 2 hours)
|
Antiretroviral therapy (ART) use influence on family planning methods assessed by focus group discussion
Time Frame: Discussion Visit (Day 0, Up to 2 hours)
|
Antiretroviral therapy (ART) use influence on family planning methods will be discussed in a focus group setting between 6-8 men or women.
Focus groups will be facilitated by a trained member of the research team.
The discussions will be audio taped and there will be a note-taker attending each group.
Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication.
Focus group discussion will take between one to two hours
|
Discussion Visit (Day 0, Up to 2 hours)
|
Antiretroviral therapy (ART) non-use influence on family planning methods assessed by focus group discussion
Time Frame: Discussion Visit (Day 0, Up to 2 hours)
|
Antiretroviral therapy (ART) non-use influence on family planning methods will be discussed in a focus group setting between 6-8 men or women.
Focus groups will be facilitated by a trained member of the research team.
The discussions will be audio taped and there will be a note-taker attending each group.
Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication.
Focus group discussion will take between one to two hours.
|
Discussion Visit (Day 0, Up to 2 hours)
|
Influence of human immunodeficiency virus (HIV) on use of dual protection assessed by focus group discussion
Time Frame: Discussion Visit (Day 0, Up to 2 hours)
|
Influence of HIV on use of dual protection will be discussed in a focus group setting between 6-8 men or women.
Focus groups will be facilitated by a trained member of the research team.
The discussions will be audio taped and there will be a note-taker attending each group.
Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication.
Focus group discussion will take between one to two hours.
|
Discussion Visit (Day 0, Up to 2 hours)
|
Influence of human immunodeficiency virus (HIV) on non-use of dual protection assessed by focus group discussion
Time Frame: Discussion Visit (Day 0, Up to 2 hours)
|
Influence of HIV on non-use of dual protection will be discussed in a focus group setting between 6-8 men or women.
Focus groups will be facilitated by a trained member of the research team.
The discussions will be audio taped and there will be a note-taker attending each group.
Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication.
Focus group discussion will take between one to two hours.
|
Discussion Visit (Day 0, Up to 2 hours)
|
Influence of antiretroviral therapy (ART) on use of dual protection assessed by focus group discussion
Time Frame: Discussion Visit (Day 0, Up to 2 hours)
|
Influence of ART on use of dual protection will be discussed in a focus group setting between 6-8 men or women.
Focus groups will be facilitated by a trained member of the research team.
The discussions will be audio taped and there will be a note-taker attending each group.
Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication.
Focus group discussion will take between one to two hours.
|
Discussion Visit (Day 0, Up to 2 hours)
|
Influence of antiretroviral therapy (ART) on non-use of dual protection assessed by focus group discussion
Time Frame: Discussion Visit (Day 0, Up to 2 hours)
|
Influence of ART on non-use of dual protection will be discussed in a focus group setting between 6-8 men or women.
Focus groups will be facilitated by a trained member of the research team.
The discussions will be audio taped and there will be a note-taker attending each group.
Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication.
Focus group discussion will take between one to two hours.
|
Discussion Visit (Day 0, Up to 2 hours)
|
Perception of sexually transmitted infection (STI) risk assessed by focus group discussion
Time Frame: Discussion Visit (Day 0, Up to 2 hours)
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Perception of sexually transmitted infection (STI) risk will be discussed in a focus group setting between 6-8 men or women.
Focus groups will be facilitated by a trained member of the research team.
The discussions will be audio taped and there will be a note-taker attending each group.
Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication.
Focus group discussion will take between one to two hours.
|
Discussion Visit (Day 0, Up to 2 hours)
|
Perception of risk of human immunodeficiency virus (HIV) transmission to partners or children assessed by focus group discussion
Time Frame: Discussion Visit (Day 0, Up to 2 hours)
|
Perception of risk of HIV transmission to partners or children will be discussed in a focus group setting between 6-8 men or women.
Focus groups will be facilitated by a trained member of the research team.
The discussions will be audio taped and there will be a note-taker attending each group.
Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication.
Focus group discussion will take between one to two hours.
|
Discussion Visit (Day 0, Up to 2 hours)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB00051780
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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