Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607693412075 Date of Registration: 24/07/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The HASHTAG Study
Official scientific title Harnessing Parental Social Networks for HIV Testing Among Children in Uganda: A Parallel-Group, Two-Arm Quasi-Experimental Study
Brief summary describing the background and objectives of the trial The HASHTAG study aims to increase HIV testing among children of female sex workers (FSWs) in Gulu City, Uganda. These children face a high risk of HIV but often miss out on testing due to stigma and limited access to healthcare. The study will train FSWs in Gulu to act as peer mentors, encouraging others in their networks to have their children tested. By leveraging these social connections, the study hopes to make HIV testing more accessible and acceptable. The goal is to improve health outcomes for these children and provide practical solutions for similar communities.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide) HASHTAG
Disease(s) or condition(s) being studied Infections and Infestations,Paediatrics
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/07/2025
Actual trial start date 01/07/2025
Anticipated date of last follow up 31/07/2026
Actual Last follow-up date 10/07/2026
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants) 300
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Parental Social Networks for HIV Testing Among Children of Female Sex Workers During the first six months of the 12-month study period, no study intervention will be delivered. Participants in both the intervention and comparison groups will continue to access HIV testing and related services through the routine HIV testing services provided in accordance with the Uganda Ministry of Health guidelines and standard of care. The HASHTAG intervention will be introduced during the final six months of the study period. The Harnessing Parental Social Networks for HIV Testing Among Children of Female Sex Workers in Uganda (HASHTAG) intervention is a contextually adapted implementation strategy based on the Social Network Strategy (SNS), developed to increase HIV testing among children of female sex workers (FSWs) who are often missed by conventional HIV testing approaches. The intervention was informed by formative research and co-developed with FSWs, peer educators, community-based organizations, healthcare providers, programme managers, policymakers, and researchers to ensure its relevance, acceptability, feasibility, and sustainability. HASHTAG leverages trusted social networks of FSWs to confidentially identify children with unknown or undocumented HIV status and link them to HIV testing services. Trained peer educators and programme staff engage FSWs through established community networks, identify eligible children, and facilitate referral to community- or facility-based HIV testing services in accordance with Uganda Ministry of Health guidelines. Children diagnosed with HIV are linked to treatment and care, while those testing HIV-negative receive appropriate HIV prevention services. The intervention was implemented through the partnership between The AIDS Support Organization (TASO) Gulu and Voice of Community Empowerment (VoiCE), a female sex worker-led community-based organization. TASO Gulu provided HIV testing and clinical services, while VoiCE led community mobilization, peer engagement, and referral of eligible children. The intervention was integrated into routine HIV service delivery, enabling evaluation under real-world programme conditions. Implementation and evaluation were conducted by separate teams with clearly defined responsibilities. The HASHTAG intervention was not publicized within the study communities, and operational details were restricted to the implementation team to minimize contamination and reduce observer and measurement bias, thereby strengthening the validity of the study findings. 150
Control Group Routine HIV testing strategy 12 months The comparative cohort will be matched 1:1 and will comprise children of non-sex working mothers matched on the neighbourhood, maternal age, child age, and child sex. The comparators must have lived in the same neighbourhood as FSW for at least the year before enrolment. The comparators will not be provided with any special intervention to improve HIV testing. 150 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Intervention Cohort (Children of Female Sex Workers) Participants were eligible for inclusion in the intervention cohort if they met all of the following criteria: Children aged 0–17 years born to female sex workers. Both male and female children were eligible. The child's mother had been actively engaged in sex work during the year preceding cohort enrolment. The child's mother did not intend to permanently relocate outside Gulu City within one year following enrolment. Matched Comparator Cohort Participants were eligible for inclusion in the matched comparator cohort if they met all of the following criteria: Children aged 0–17 years whose mothers were not female sex workers. The comparator child had resided in the same neighbourhood as the corresponding intervention participant for at least one year before enrolment. The comparator child was matched to the intervention child by age (±2 years). The comparator child was of the same sex as the corresponding intervention child. The comparator child's mother was not engaged in sex work. The comparator child's mother was matched to the intervention child's mother by age (±5 years). The comparator child's mother did not intend to permanently relocate outside Gulu City within one year following enrolment. The following participants will be excluded from the study: Mothers who are bedridden and therefore unable to participate in study procedures. Mothers who are mentally incapacitated and unable to provide informed consent. Mothers who do not understand either English or Acholi, the languages used for study procedures. Mothers who decline or are unable to provide written informed consent. Children: No exclusion criteria will be applied to children. As children are not active study participants but beneficiaries of the HIV testing intervention, they will not be excluded on the basis of age, health status, disability, or any other characteristic, as they may benefit from HIV testing services regardless of their circumstances. Adolescent: 13 Year(s)-17 Year(s),Child: 6 Year-12 Year,Infant: 1 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 0 Year(s) 17 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/02/2025 The AIDS Support Organization REC
Ethics Committee Address
Street address City Postal code Country
Old Mulago Complex, Kampala Kampala 10443 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of children with known HIV status. The pre-intervention period comprised months 0-6. The post-intervention period comprised months 7-12. Outcomes assessed monthly.
Secondary Outcome Implementation science outcomes Month 12
Secondary Outcome Health economic outcomes Month 12
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Gulu City Gulu City Gulu City Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
IPHASA Avenue de France 23 Geneva CH-1202 G Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor The AIDS Support Organization Old Mulago Complex Kampala 10443 Uganda Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Dr. Josephine Birungi Plot 51-59 Nakiwogo Road Entebbe 49 Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Simple Ouma oumasimple@gmail.com +256775989311 Old Mulago Complex
City Postal code Country Position/Affiliation
Kampala 10443 Uganda Research Manager
Role Name Email Phone Street address
Public Enquiries Simple Ouma oumasimple@gmail.com +256775989311 Old Mulago Complex
City Postal code Country Position/Affiliation
Kampala 10443 Uganda Research Manager
Role Name Email Phone Street address
Scientific Enquiries Simple Ouma oumasimple@gmail.com +256775989311 Old Mulago Complex
City Postal code Country Position/Affiliation
Kampala 10443 Uganda Research Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data underlying the results reported in publications arising from the HASHTAG study will be made available upon reasonable request to the Principal Investigator following publication of the primary study findings. Data sharing will be considered for researchers with a scientifically sound proposal, subject to approval by the study investigators, TASO Research Ethics Committee, and any other relevant regulatory bodies, where applicable. Only de-identified participant-level data and the accompanying data dictionary will be shared to safeguard participant confidentiality. Data will be made available beginning within 12 months after completion of the study and publication of the primary results and will remain available for up to five years thereafter. Requests for access should be accompanied by a methodologically sound research proposal and, where appropriate, evidence of ethical approval and a signed data-sharing agreement specifying the intended use of the data. Summary study results will be disseminated through peer-reviewed publications, scientific conferences, stakeholder meetings, and the trial registration record, in accordance with WHO recommendations. Study Protocol 5 years open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 11/07/2026 Response to review comments. The target group for Intervention: We shall invite FSW with at least one child aged 0-17 years. For mothers to be categorized as FSW, each must have received money or goods in exchange for sexual services and consciously defined their activities as income-generating. In addition, we shall enrol active FSW who have been conducting sex work during the one year before setting up the cohort. Thus, maternal sex work status will be ascertained using three questions as follows: 1) Have you ever received money or goods in exchange for sexual services? 2) If yes, have you received money or goods in exchange for sexual services in the last year? 3) If yes, do you consider your receipt of money or goods for sexual services as income-generating? Mothers who answered "yes" to all three questions will be considered FSW. Conversely, mothers who answer "no" to either questions 2 or 3 will be considered non-FSW and be eligible to participate if they have been living in the same neighbourhood as the FSW in the past year before setting up the cohort (Attachment 1). We shall enrol only FSW who do not plan to move outside the greater Gulu in the one year following recruitment into the cohort. The comparator cohort: The comparative cohort will be matched 1:1 and will comprise non-sex working mothers matched on the neighbourhood, maternal age, child age, and child sex. The comparators must have lived in the same neighbourhood as FSW for at least the year before enrolment. Likewise, we shall enrol only non-FSWs who do not plan to move outside the greater Gulu in the one year following recruitment into the cohort. The children: Much as children of FSW are the direct target of the intervention, we shall not directly involve them as active participants in the cohort. Children of FSW will be randomly selected from both sexes and without stratification. Meanwhile, children of non-FSW will be matched to children on FSW in the neighbourhood, maternal age, child age, and child sex. Intervention Cohort (Children of Female Sex Workers) Participants were eligible for inclusion in the intervention cohort if they met all of the following criteria: Children aged 0–17 years born to female sex workers. Both male and female children were eligible. The child's mother had been actively engaged in sex work during the year preceding cohort enrolment. The child's mother did not intend to permanently relocate outside Gulu City within one year following enrolment. Matched Comparator Cohort Participants were eligible for inclusion in the matched comparator cohort if they met all of the following criteria: Children aged 0–17 years whose mothers were not female sex workers. The comparator child had resided in the same neighbourhood as the corresponding intervention participant for at least one year before enrolment. The comparator child was matched to the intervention child by age (±2 years). The comparator child was of the same sex as the corresponding intervention child. The comparator child's mother was not engaged in sex work. The comparator child's mother was matched to the intervention child's mother by age (±5 years). The comparator child's mother did not intend to permanently relocate outside Gulu City within one year following enrolment.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 11/07/2026 Response to review comments. We shall exclude; all bedridden or mentally incapacitated mothers from the study. Note that since children will not be active study participants, we shall not exclude them on any ground since they might benefit from HIV testing services regardless of their status. In addition, we shall exclude mothers who do not understand English or Acholi language. Mothers who do not consent to participate in the study will be excluded. The following participants will be excluded from the study: Mothers who are bedridden and therefore unable to participate in study procedures. Mothers who are mentally incapacitated and unable to provide informed consent. Mothers who do not understand either English or Acholi, the languages used for study procedures. Mothers who decline or are unable to provide written informed consent. Children: No exclusion criteria will be applied to children. As children are not active study participants but beneficiaries of the HIV testing intervention, they will not be excluded on the basis of age, health status, disability, or any other characteristic, as they may benefit from HIV testing services regardless of their circumstances.
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 11/07/2026 Making adjustement to clarify pre-intervention and post-intervention period Primary Outcome, Effectiveness of parental SNS in improving uptake of HIV testing service among children of FSW aged 0-17 years., Monthly from month 0 to month 12 Primary Outcome, Proportion of children with known HIV status., The pre-intervention period comprised months 0-6. The post-intervention period comprised months 7-12. Outcomes assessed monthly.