Clinical trial NCT02667808: Exploring the Impact of HIV and ART on Knowledge, Attitudes and Practices in Reproductive Health in Lilongwe, Malawi
Official title: Exploring the Impact of HIV and ART on Knowledge, Attitudes and Practices in Reproductive Health in Lilongwe, Malawi
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
AIDS
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2016-01-29
Enrollment: 562
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons living with HIV in Lilongwe, Malawi recruited from The Lighthouse Trust Clinic

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.

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

Primary outcomes:
measure: Perception of ideal family size assessed by focus group discussion
timeFrame: Discussion Visit (Day 0, Up to 2 hours)
measure: Perception of social pressures regarding fertility intentions assessed by focus group discussion
timeFrame: Discussion Visit (Day 0, Up to 2 hours)
measure: Perception of familial pressures regarding fertility intentions assessed by focus group discussion
timeFrame: Discussion Visit (Day 0, Up to 2 hours)
measure: Perception of partner pressures regarding fertility intentions assessed by focus group discussion
timeFrame: Discussion Visit (Day 0, Up to 2 hours)
measure: Influence of human immunodeficiency virus (HIV) on fertility intentions assessed by focus group discussion
timeFrame: Discussion Visit (Day 0, Up to 2 hours)
measure: Influence of antiretroviral therapy (ART) on fertility intentions assessed by focus group discussion
timeFrame: Discussion Visit (Day 0, Up to 2 hours)
measure: Perception of concordance among couples on fertility intention assessed by focus group discussion
timeFrame: Discussion Visit (Day 0, Up to 2 hours)
measure: Perception of how relationship status influences fertility intentions assessed by focus group discussion
timeFrame: Discussion Visit (Day 0, Up to 2 hours)
measure: Perception of how reproductive health issues impact fertility intentions assessed by focus group discussion
timeFrame: Discussion Visit (Day 0, Up to 2 hours)
measure: Knowledge regarding family planning methods assessed by focus group discussion
timeFrame: Discussion Visit (Day 0, Up to 2 hours)
measure: Knowledge regarding family planning misconceptions assessed by focus group discussion
timeFrame: Discussion Visit (Day 0, Up to 2 hours)
measure: Current family planning methods assessed by focus group discussion
timeFrame: Discussion Visit (Day 0, Up to 2 hours)
measure: Previously used family planning methods assessed by focus group discussion
timeFrame: Discussion Visit (Day 0, Up to 2 hours)
measure: Intent to use family planning methods assessed by focus group discussion
timeFrame: Discussion Visit (Day 0, Up to 2 hours)
measure: Perception of social influence on family planning methods assessed by focus group discussion
timeFrame: Discussion Visit (Day 0, Up to 2 hours)
measure: Perception of familial influence on family planning methods assessed by focus group discussion
timeFrame: Discussion Visit (Day 0, Up to 2 hours)
measure: Perception of partner influence on family planning methods assessed by focus group discussion
timeFrame: Discussion Visit (Day 0, Up to 2 hours)
measure: Human immunodeficiency virus (HIV) influence on family planning methods assessed by focus group discussion
timeFrame: Discussion Visit (Day 0, Up to 2 hours)
measure: Antiretroviral therapy (ART) use influence on family planning methods assessed by focus group discussion
timeFrame: Discussion Visit (Day 0, Up to 2 hours)
measure: Antiretroviral therapy (ART) non-use influence on family planning methods assessed by focus group discussion
timeFrame: Discussion Visit (Day 0, Up to 2 hours)
measure: Influence of human immunodeficiency virus (HIV) on use of dual protection assessed by focus group discussion
timeFrame: Discussion Visit (Day 0, Up to 2 hours)
measure: Influence of human immunodeficiency virus (HIV) on non-use of dual protection assessed by focus group discussion
timeFrame: Discussion Visit (Day 0, Up to 2 hours)
measure: Influence of antiretroviral therapy (ART) on use of dual protection assessed by focus group discussion
timeFrame: Discussion Visit (Day 0, Up to 2 hours)
measure: Influence of antiretroviral therapy (ART) on non-use of dual protection assessed by focus group discussion
timeFrame: Discussion Visit (Day 0, Up to 2 hours)
measure: Perception of sexually transmitted infection (STI) risk assessed by focus group discussion
timeFrame: Discussion Visit (Day 0, Up to 2 hours)
measure: Perception of risk of human immunodeficiency virus (HIV) transmission to partners or children assessed by focus group discussion
timeFrame: Discussion Visit (Day 0, Up to 2 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: The Lighthouse Trust
Study officials:
affiliation: Emory University
name: Lisa Haddad, MD
role: PRINCIPAL_INVESTIGATOR
References: