Exploring the Impact of HIV and ART on Knowledge, Attitudes and Practices in Reproductive Health in Lilongwe, Malawi

HIV Clinical Trial

— HIV KAP  

Official title:

Exploring the Impact of HIV and ART on Knowledge, Attitudes and Practices in Reproductive Health in Lilongwe, Malawi

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02667808
• Other study ID #: IRB00051780
• Status: Completed
• Phase: N/A
• First received: January 26, 2016
• Last updated: February 8, 2017
• Start date: August 2011
• Est. completion date: December 2013

Study information

• Verified date: January 2017
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 562
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• AIDS
• HIV

Intervention

Other:
• Focus Group
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 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.

Locations

Country	Name	City	State
Malawi	The Lighthouse Trust	Lilongwe

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perception of ideal family size assessed by focus group discussion	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)
Primary	Perception of social pressures regarding fertility intentions assessed by focus group discussion	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)
Primary	Perception of familial pressures regarding fertility intentions assessed by focus group discussion	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)
Primary	Perception of partner pressures regarding fertility intentions assessed by focus group discussion	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)
Primary	Influence of human immunodeficiency virus (HIV) on fertility intentions assessed by focus group discussion	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)
Primary	Influence of antiretroviral therapy (ART) on fertility intentions assessed by focus group discussion	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)
Primary	Perception of concordance among couples on fertility intention assessed by focus group discussion	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)
Primary	Perception of how relationship status influences fertility intentions assessed by focus group discussion	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)
Primary	Perception of how reproductive health issues impact fertility intentions assessed by focus group discussion	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)
Primary	Knowledge regarding family planning methods assessed by focus group discussion	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)
Primary	Knowledge regarding family planning misconceptions assessed by focus group discussion	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)
Primary	Current family planning methods assessed by focus group discussion	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)
Primary	Previously used family planning methods assessed by focus group discussion	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)
Primary	Intent to use family planning methods assessed by focus group discussion	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)
Primary	Perception of social influence on family planning methods assessed by focus group discussion	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)
Primary	Perception of familial influence on family planning methods assessed by focus group discussion	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)
Primary	Perception of partner influence on family planning methods assessed by focus group discussion	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)
Primary	Human immunodeficiency virus (HIV) influence on family planning methods assessed by focus group discussion	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)
Primary	Antiretroviral therapy (ART) use influence on family planning methods assessed by focus group discussion	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)
Primary	Antiretroviral therapy (ART) non-use influence on family planning methods assessed by focus group discussion	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)
Primary	Influence of human immunodeficiency virus (HIV) on use of dual protection assessed by focus group discussion	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)
Primary	Influence of human immunodeficiency virus (HIV) on non-use of dual protection assessed by focus group discussion	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)
Primary	Influence of antiretroviral therapy (ART) on use of dual protection assessed by focus group discussion	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)
Primary	Influence of antiretroviral therapy (ART) on non-use of dual protection assessed by focus group discussion	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)
Primary	Perception of sexually transmitted infection (STI) risk assessed by focus group discussion	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)
Primary	Perception of risk of human immunodeficiency virus (HIV) transmission to partners or children assessed by focus group discussion	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)