Data category | Information |
---|---|
Title | A Stigma Reduction Intervention at Time of Entry into Antenatal Care to Improve PMTCT Services in Tanzania (Maisha) |
Primary registry and trial identifying number | NCT03600142 Registered July 25, 2018 |
Secondary identifying numbers | R21 TW011053 (US NIH Grant/Contract) |
Primary funder | Fogarty International Center (NIH) |
Contact for public queries | Melissa Watt, PhD |
Countries of recruitment | Tanzania |
Health condition(s) or problem(s) studied | HIV care engagement HIV stigma |
Key inclusion and exclusion criteria | Ages eligible: 18 years and older Sexes eligible: all Accepts healthy volunteers: yes Inclusion criteria: 18 years of age or older If female: pregnant and attending first antenatal care (ANC) appointment for the current pregnancy at one of the two study sites If male: accompanying an enrolled woman to her first ANC appointment. Exclusion criteria: Impaired mental status Does not speak Swahili |
Study type | Pilot feasibility trial Allocation: randomized Allocation ratio: 1:1 Intervention model: parallel assignment |
Date of first enrollment | April 8, 2019 |
Target sample size | 1700 participants |
Recruitment status | Recruiting |
Primary outcome(s) | HIV care retention (female HIV-infected participants only) (time frame: post assessment (3 months after enrollment)) Internalized HIV stigma (HIV-infected participants only) (time frame: post assessment (3 months after enrollment)) Attitudes toward people living with HIV (HIV-uninfected participants only) (time frame: post assessment (3 months after enrollment)) |
Key secondary outcomes | ART adherence (HIV-infected participants only) (time frame: post assessment (3 months after enrollment)) Depression (HIV-infected participants only) (time frame: post assessment (3 months after enrollment)) HIV disclosure (HIV-infected participants only) (time frame: post assessment (3 months after enrollment)) Anticipated HIV stigma (all participants) (time frame: post assessment (3 months after enrollment)) Linkage to HIV care (male HIV-infected participants only) (time frame: post assessment (3 months after enrollment)) Willingness to test for HIV in the future (HIV-uninfected participants only) (time frame: post assessment (3 months after enrollment)) |