CClinicalTrials.gg
CompletedNCT02667808HIV KAPUpdated Feb 9, 2017

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

An observational study in HIV and AIDS, sponsored by Emory University. Completed at 1 site in Malawi. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2017-02-09.

Sponsored by Emory University · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
562
Ages
18 Years to 55 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • HIV
  • AIDS
03

In context

Lead sponsor

Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.

Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Persons living with HIV in Lilongwe, Malawi recruited from The Lighthouse Trust Clinic

Eligibility criteria

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

05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
562 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Other: Focus Group

  • 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.

    Other: Questionnaire

Interventions

  • OtherFocus 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.

  • OtherQuestionnaire

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Discussion Visit (Day 0, Up to 2 hours)

  2. 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.

    Time frame: Discussion Visit (Day 0, Up to 2 hours)

  3. 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.

    Time frame: Discussion Visit (Day 0, Up to 2 hours)

  4. 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.

    Time frame: Discussion Visit (Day 0, Up to 2 hours)

  5. 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.

    Time frame: Discussion Visit (Day 0, Up to 2 hours)

  6. 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.

    Time frame: Discussion Visit (Day 0, Up to 2 hours)

  7. 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.

    Time frame: Discussion Visit (Day 0, Up to 2 hours)

  8. 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.

    Time frame: Discussion Visit (Day 0, Up to 2 hours)

  9. 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.

    Time frame: Discussion Visit (Day 0, Up to 2 hours)

  10. 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.

    Time frame: Discussion Visit (Day 0, Up to 2 hours)

  11. 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.

    Time frame: Discussion Visit (Day 0, Up to 2 hours)

  12. 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.

    Time frame: Discussion Visit (Day 0, Up to 2 hours)

  13. 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.

    Time frame: Discussion Visit (Day 0, Up to 2 hours)

  14. 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.

    Time frame: Discussion Visit (Day 0, Up to 2 hours)

  15. 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.

    Time frame: Discussion Visit (Day 0, Up to 2 hours)

  16. 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.

    Time frame: Discussion Visit (Day 0, Up to 2 hours)

  17. 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.

    Time frame: Discussion Visit (Day 0, Up to 2 hours)

  18. 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.

    Time frame: Discussion Visit (Day 0, Up to 2 hours)

  19. 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

    Time frame: Discussion Visit (Day 0, Up to 2 hours)

  20. 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.

    Time frame: Discussion Visit (Day 0, Up to 2 hours)

  21. 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.

    Time frame: Discussion Visit (Day 0, Up to 2 hours)

  22. 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.

    Time frame: Discussion Visit (Day 0, Up to 2 hours)

  23. 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.

    Time frame: Discussion Visit (Day 0, Up to 2 hours)

  24. 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.

    Time frame: Discussion Visit (Day 0, Up to 2 hours)

  25. 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.

    Time frame: Discussion Visit (Day 0, Up to 2 hours)

  26. 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.

    Time frame: Discussion Visit (Day 0, Up to 2 hours)

07

Study locations

1 site
  • The Lighthouse Trust
    Lilongwe, Malawi
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02667808
Lead sponsor
Emory University
Responsible party
Lisa Haddad (Assistant Professor, Emory University) — Principal investigator
First posted
Jan 29, 2016
Start date
Aug 2011
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Feb 9, 2017

Study contacts

Lisa Haddad, MD
principal investigator · Emory University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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