Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06647797
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
Enhancing Communication on Relationship Preservation Safer Conception and PrEP to Promote HIV Testing in Uganda
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Enhancing Communication on Relationship Preservation Safer Conception and PrEP to Promote HIV Testing in Uganda
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Our novel communication strategy aims to promote HIV testing in Uganda with reassuring messages about the ability to have stable relationships and healthy families with the increased availability of pre-exposure prophylaxis PrEP We will evaluate the feasibility and acceptability of this communication strategy among clients and partners within assisted partner notification and antenatal care programs in two hospitals and evaluate preliminary effects
Detailed Description:
Optimizing uptake of HIV testing is critical to meeting 95-95-95 goals in sub-Saharan Africa As 30 of new infections in occur within married or cohabitating couples maximizing testing among individuals who are or may someday be in serious heterosexual relationships has been identified as one of the most cost-effective strategies to curb the epidemic Childbearing is highly valued throughout Sub-Saharan Africa and fears of relationship dissolution and loss of the ability to have children remain significant barriers to HIV testing The expanding availability of pre-exposure prophylaxis PrEP presents an opportunity to counter these fears with strategic communication NOT-MH-21-105 that reassure couples of their ability to have a healthy family even if one or both members are HIV positive Our long-term objective is to leverage the growing availability of PrEP to determine if and how a communication strategy focused on relationship preservation and safer conception can increase testing and entry into treatment antiretroviral therapy or prevention PrEP among partnered individuals in Uganda We recently successfully piloted this communication strategy within Ugandas assisted partner notification program APN In this R34 we will 1 conduct formative research to expand the communication strategy into a multi-component intervention with broader reach and 2 conduct a pilot trial of the intervention PrEPing Healthy Families To achieve Aim 1 we will work with a community advisory board CAB of providers to a create communication materials brochures scripts and counseling protocols tailored to clients and partners across the array of couples testing pathways in APN and antenatal care ANC As CAB providers pilot materials and tracking systems with clients and partners during this development phase study staff will conduct field observations and qualitative interviews focused on feasibility and acceptability informing revised intervention materials To achieve Aim 2 we will collect baseline data at APN and ANC clinics within two large public healthcare facilities over nine months Sites will then be randomized to implement PrEPing Healthy Families or their existing communication approach usual care over the next nine months We will collect mixed-methods data on feasibility and acceptability through intervention tracking in APNANC registers client exit surveys and qualitative interviews with clients partners and providers Through register extraction we will examine limited efficacy on outcomes that would be relevant to a larger trial partner HIV testing client service uptake initiation of PrEPART and explore potential moderators Overall results will yield important insights in a promising new communication strategy NOT-MH-21-105 that may connect more individuals to the HIV cascades of care for treatment or prevention and prepare us for a large-scale cluster randomized controlled trial to determine impact on testing and initiation of PrEPART
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None