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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202209769991162 Date of Approval: 26/09/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Randomized Control Trial for the Effectiveness of mobile phone call invitation to HIV partner counseling and testing at the antenatal care in Moshi District Tanzania.
Official scientific title Randomized Control Trial for the Effectiveness of mobile phone call invitation to HIV partner counseling and testing at the antenatal care in Moshi District Tanzania.
Brief summary describing the background and objectives of the trial In Tanzania, HIV partner counseling and testing in antenatal care is a crucial strategy to raise the number of males who knows their HIV status. Currently, a male invitation to ANC is the responsibility of pregnant women. Using this invitation strategy, only 30% and 8% of male partners attend and test for HIV, respectively. This low response rate may be due to several factors, including domestic violence, infidelity, and fear of HIV-positive results, making pregnant women less likely to invite their male partners. This study aims at current study aims to assess the effectiveness of health care providers using mobile phones to invite males for ANC services in Moshi District, Tanzania.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 08/08/2022
Actual trial start date 15/08/2022
Anticipated date of last follow up 15/11/2022
Actual Last follow-up date 15/11/2022
Anticipated target sample size (number of participants) 350
Actual target sample size (number of participants)
Recruitment status Recruiting
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 Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Mobile phone call and text message NA This study will take place for eight weeks For the intervention arm, pregnant women attending ANC without partners will be asked to provide the phone numbers of their male partners for the healthcare provider to invite their partner to attend ANC; apart from that, pregnant women were instructed to invite their husbands verbally. The control arm will be instructed to invite partners only verbally, and there will be no health care involvement. Partner attendance will be recorded at two subsequent ANC visits. The proportion of male partner attendance, partner voluntary counselling and testing (PVCT), and associated factors will be analyzed. 175
Control Group Standard of care involving asking pregnant women to verbally invite their patners NA Duration of the study is eight weeks In the Control group (Verbal invitation only), pregnant women were told to verbally invite and come with their partner to the ANC visit as a standard of care. When woman came without partner to the second visit (after 4weeks) were remained again to invite their partner for the next visit (third visit). 175 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age eligible for the study 18-49 Pregnant women who came without a male partner during their first ANC visit in their current pregnancy. Clients will be excluded from the trial: Pregnant women with partners had no phones at home or had tested for HIV during the current pregnancy with documented results. Adult: 19 Year-44 Year 18 Year(s) 49 Year(s) Male
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 10/03/2022 Kilimanjaro Christian Medical University College IRB
Ethics Committee Address
Street address City Postal code Country
Moshi Moshi 25116 Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Male partner HIV testing One time point - At exit
Primary Outcome male partner attendence,factors associate with male partner attendance example work,unplanned pregnancy, marital status, entry
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Majengo health facility and St.Joseph hospital Moshi Municipal Moshi 25116 Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Transforming Health education in Tanzania 2240 Moshi Moshi 25102 Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Transforming Health Education in Tanzania Moshi 2240 Moshi 25105 United Republic of Tanzania University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Angela Lyimo angelalyimo89@gmail.com 0759586391 Moshi 2240
City Postal code Country Position/Affiliation
Moshi 25102 United Republic of Tanzania Assistant lecturer
Role Name Email Phone Street address
Scientific Enquiries James Ngocho jamesngocho08@gmail.com 0784640164 Moshi
City Postal code Country Position/Affiliation
Moshi 25105 Tanzania Lecturer
Role Name Email Phone Street address
Public Enquiries Blandina Mmbaga blaymt@gmail.com 0768435116 Moshi
City Postal code Country Position/Affiliation
Moshi 25105 United Republic of Tanzania Senior lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial after deidentification example text,table,figures and appendices Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol After publication of the article Data will be available with publication, they will be open access type of data for anyone interested to use.
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