Overview

This trial is active, not recruiting.

Conditions hiv, aids
Treatments focus group, questionnaire
Sponsor Emory University
Start date August 2011
End date December 2013
Trial size 562 participants
Trial identifier NCT02667808, IRB00051780

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective cross-sectional
Arm
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.
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.
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.
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.

Primary Outcomes

Measure
Perception of ideal family size assessed by focus group discussion
time frame: 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 familial 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 assessed by focus group discussion
time frame: 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 antiretroviral therapy (ART) on fertility intentions assessed by focus group discussion
time frame: 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)
Perception of how relationship status influences fertility intentions assessed by focus group discussion
time frame: 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)
Knowledge regarding family planning methods assessed by focus group discussion
time frame: 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)
Current family planning methods assessed by focus group discussion
time frame: Discussion Visit (Day 0, Up to 2 hours)
Previously used family planning methods assessed by focus group discussion
time frame: Discussion Visit (Day 0, Up to 2 hours)
Intent to use 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 assessed by focus group discussion
time frame: 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 partner 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 assessed by focus group discussion
time frame: 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) non-use influence on family planning methods assessed by focus group discussion
time frame: 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 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 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 antiretroviral therapy (ART) on non-use of dual protection assessed by focus group discussion
time frame: 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)
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)

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

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

Additional Information

Official title Exploring the Impact of HIV and ART on Knowledge, Attitudes and Practices in Reproductive Health in Lilongwe, Malawi
Principal investigator Lisa Haddad, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Emory University.