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

Completed

• Conditions: HIV; AIDS
• Interventions: Other: Focus Group; Other: Questionnaire

• Registration Number: NCT02667808
• Lead Sponsor: Emory University

Brief 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).

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 Timeline

• Study Start: 2011-08
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Study First Submitted: 2016-01-26
• Study First Submitted QC: 2016-01-26
• Study First Posted: 2016-01-29
• Status Verified: 2017-01
• Last Update Submitted: 2017-02-08
• Last Update Posted: 2017-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 562

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Focus Group	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.
Questionnaire	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.

Primary Outcome Measures

Name	Time	Method
Previously used family planning methods assessed by focus group discussion	Discussion Visit (Day 0, Up to 2 hours)	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.
Intent to use family planning methods assessed by focus group discussion	Discussion Visit (Day 0, Up to 2 hours)	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.
Antiretroviral therapy (ART) use influence on family planning methods assessed by focus group discussion	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
Influence of human immunodeficiency virus (HIV) on use of dual protection assessed by focus group discussion	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.
Influence of human immunodeficiency virus (HIV) on non-use of dual protection assessed by focus group discussion	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.
Perception of social pressures regarding fertility intentions assessed by focus group discussion	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.
Perception of how reproductive health issues impact fertility intentions assessed by focus group discussion	Discussion Visit (Day 0, Up to 2 hours)	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.
Perception of partner influence on family planning methods assessed by focus group discussion	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.
Human immunodeficiency virus (HIV) influence on family planning methods assessed by focus group discussion	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.
Perception of ideal family size assessed by focus group discussion	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.
Perception of familial pressures regarding fertility intentions assessed by focus group discussion	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.
Perception of partner pressures regarding fertility intentions assessed by focus group discussion	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.
Influence of antiretroviral therapy (ART) on fertility intentions assessed by focus group discussion	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.
Perception of concordance among couples on fertility intention assessed by focus group discussion	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.
Influence of human immunodeficiency virus (HIV) on fertility intentions assessed by focus group discussion	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.
Antiretroviral therapy (ART) non-use influence on family planning methods assessed by focus group discussion	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.
Perception of how relationship status influences fertility intentions assessed by focus group discussion	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.
Perception of social influence on family planning methods assessed by focus group discussion	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.
Perception of familial influence on family planning methods assessed by focus group discussion	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.
Knowledge regarding family planning methods assessed by focus group discussion	Discussion Visit (Day 0, Up to 2 hours)	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.
Knowledge regarding family planning misconceptions assessed by focus group discussion	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.
Current family planning methods assessed by focus group discussion	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.
Influence of antiretroviral therapy (ART) on use of dual protection assessed by focus group discussion	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.
Perception of risk of human immunodeficiency virus (HIV) transmission to partners or children assessed by focus group discussion	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.
Influence of antiretroviral therapy (ART) on non-use of dual protection assessed by focus group discussion	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.
Perception of sexually transmitted infection (STI) risk assessed by focus group discussion	Discussion Visit (Day 0, Up to 2 hours)	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.

Trial Locations

Locations (1)

The Lighthouse Trust; 🇲🇼 Lilongwe, Malawi