NCT07807670

Brief Summary

The overall objective of the Pregnant and Parenting Girls (P2G) Program evaluation was to measure resilience among pregnant and parenting girls (18 years and above) living with HIV in Lusaka who have benefitted from the comprehensive package of interventions under P2G program. The main purpose of the P2G program was to increase resilience and improve treatment outcomes among HIV positive adolescent pregnant and parenting mothers (10-19 years), through provision of SRH education, ART adherence, skills development, mentorship, mother-baby pairing, and young father involvement.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,257

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 17, 2020

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2024

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2026

Completed
29 days until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
Last Updated

September 8, 2026

Status Verified

September 1, 2026

Enrollment Period

4.4 years

First QC Date

August 10, 2026

Last Update Submit

September 3, 2026

Conditions

Keywords

Pregnant Adolescent GirlsP2GTeen MothersHIV PositiveGirls for GirlsG4GTingatheSRHR

Outcome Measures

Primary Outcomes (1)

  • Building Resilience

    A mixed methods study using a sequential design of qualitative and quantitative indicators at baseline and end line. A quantitative self- administered paper-based survey consisting of seventeen questions to assess the resilience levels and self-efficacy, using the adapted Child Youth Resilience Measure (CYRM-28) standard. Qualitative methods used at baseline and endline to understand SRHR knowledge level and practices on treatment and adherence, and the level of male partner involvement in perinatal clinic visits. To collect this qualitative data, the study uses Focus Group Discussions and In-Depth Interviews with adolescent mothers living with HIV/AIDS and young fathers as well as Key Informant Interviews (KII) with Adolescents focal point person and Caregivers. For routine data collection, District Health Information system 2 (DHIS2) will be used by trained study personnel. This design aims to provide an In-depth understanding of resilience, treatment adherence, and PMTCT.

    From participant enrolment to completion of post-intervention resilience assessment after receiving the comprehensive support package. A participant qualified for resilience assessment if they have been exposed to intervention for minimum of 6 months.

Study Arms (1)

Pregnant and Parenting teens

EXPERIMENTAL

Young mothers and pregnant teens recruited will be engaged in the program interventions which include regular support group sessions where they receive skills development in bead making, basket making, decorative bottles, handbags, bracelets and trinkets, reusable pads, face make-up, etc. and in financial literacy. Beneficiaries are also grouped into mentorship circles for the G4G mentorship sessions which is focused on leadership, communication, and negotiation skills. It is envisaged that at the end of these sessions (curriculum of 12 G4G sessions) young girls are able to lead, speak up, negotiate and gain confidence. Treatment supporters are assigned to all breast-feeding teen mothers to ensure that mother-infant pairs receive all necessary PMTCT services. HIV exposed babies and their mothers are tracked over the project period or until the baby is 24 months old with the final HIV status outcome recorded. SRHR education is also provided through peer educators.

Other: P2G comprehensive package

Interventions

The P2G project aims to increase resilience and improve treatment adherence among HIV positive pregnant and parenting girls aged 10 to 19 years by administering a comprehensive set of proven interventions which include formation of adolescent mother support groups, skills development, education in sexual reproductive health and rights (SRHR), mother baby pairing (Tingathe model), Girls for Girls (G4G) mentorship as well as young father involvement in pre and postnatal period. It is envisaged that these interventions will impact on resilience of the project beneficiaries including adherence to HIV treatment for both mother and baby and prevention of HIV transmission from mother to baby. The project is using trained adolescent peers to deliver the package of interventions as well as engage treatment supporters to follow up mother-baby pairs for treatment adherence and keeping clinic appointments.

Also known as: SRHR education sessions, Teen Mother support groups, Skills development, Mother-baby paring (Tingathe), Young father involvement sessions, Girls for Girls (G4G) mentorship sessions
Pregnant and Parenting teens

Eligibility Criteria

Age10 Years - 19 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsGirls who are pregnant or have a child who is under 2 years old
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • HIV positive
  • Adolescent girls \>18 years old
  • Pregnant or
  • parenting a baby \<2 years old
  • Voluntary/informed consent

You may not qualify if:

  • HIV Negative
  • Not pregnant or parenting a child \>2 years old
  • Unwilling to provide consent
  • \< 18 years of age
  • newly recruited in P2G program (less than 6 months exposure to intervention)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanyama General Hospital Youth Friendly Space (YFS) Matero General Hospital YFS George Clinic YFS Mandevu Clinic YFS Chilenje Level 1 YFS Chainda Clinic YFS Bauleni clinic YFS Mtendere Clinic YFS Chawama General Hospital YFS Chipata General Hospital YFS

Lusaka, Lusaka Province, 10101, Zambia

Location

MeSH Terms

Conditions

HIV Seropositivity

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Anjali SHARMA, PhD

    Centre for Infectious Disease Research in Zambia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: Participants were required to receive atleast two services or more from the comprehensive package for a minimum of six months up to the end of the program.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2026

First Posted

September 8, 2026

Study Start

April 17, 2020

Primary Completion

September 18, 2024

Study Completion

November 28, 2024

Last Updated

September 8, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

Locations