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Table 1 Study summary (template adapted from the World Health Organization Trial Registration Data Set)

From: A counseling intervention to address HIV stigma at entry into antenatal care in Tanzania (Maisha): study protocol for a pilot randomized controlled trial

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

ClinicalTrials.gov

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

melissa.watt@utah.edu

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))

  1. ART antiretroviral therapy, HIV human immunodeficiency virus, NIH National Institutes of Health, PMTCT prevention of mother-to-child transmission