Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06171503 |
| Other study ID # |
IHRPGD/549/21 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 22, 2022 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
December 2023 |
| Source |
Jimma University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Prevention of mother to child transmission (PMTCT) of human immune deficiency virus (HIV)
program requires great male participation in achieving a sustained reduction of
mother-to-child transmission of HIV. Many strategies have been employed to promote male
participation in antenatal care but few have been assessed to convey important lessons for
scale-up. In Ethiopia, though there is no evidence on its effectiveness, letter of invitation
has been tried as a means to promote participation of men in PMTCT program at antenatal care.
The study is carried out in two public hospitals to evaluate the effect of letter of
invitation delivered through mother support group counselling on male involvement at
antenatal care clinic.
The findings of this study will directly benefit pregnant women attending antenatal clinic in
utilizing PMTCT service effectively. The formal letter of invitation proposed may be
incorporated by health service provider in their routine antenatal clinic. It will also help
the policy makers to give greater priority to reach and involve men, and to develop effective
policies as well as programs to overcome the challenges. Thus, an increase in the uptake of
PMTCT services will ultimately lead to a reduction in pediatrics HIV infection.
Description:
.
Background:
Prevention of mother to child transmission of HIV program requires great male participation.
Currently, it is well known that male involvement (MI) in PMTCT as critical steps in reducing
pediatric HIV infection. Male partner's involvement in maternal health service is reported to
be associated with increased uptake of antenatal care, improve facility-based delivery,
contraception use and decreased mother-to-child transmission of HIV. Some evidences also
showed that when couples receive counseling together, there is a better use of infant feeding
methods, have a higher acceptance of HIV testing, promotes couple communication, mutual
disclosure, mutual decision making on issues to do with safer sex. Similarly, a study from
Kenya reported that male partner's involvement in antenatal care is associated with low risk
of HIV infection in infants of HIV infected women, greater HIV free survival and reduce
infant mortality by up to 40 % . However, in the majority of SSA male involvement is still
small particularly partner testing rate is low. In Ethiopia, the ministry of health policy
advocates for HIV counseling and testing of male partners in ANC setting. In spite of this
policy, the proportion of male partners of ANC attendees testing for HIV in these setting is
low. For instance, in 2012, the rates of MI in PMTCT remain low in Ethiopia, only 20% of
antenatal women being accompanied by their partners despite the government is trying to make
it 50%.
Studies showed that several barriers to male involvement (MI) in ANC and PMTCT of HIV
service. The identified barriers were individual, socio-economic, cultural and
health-system-related barrier. To respond for the factors, Ethiopia has made major efforts
through the scale up of PMTCT program. Yet, MI in the program still remains a major obstacle
to a national response to achieving elimination of mother to child transmission(eMTCT) of HIV
for the country. Increasing MI in ANC and PMTCT services requires innovation and
evidence-based strategies to overcome barriers to participation towards the eMTCT agenda.
Many countries have used different strategies to promote participation of men in ANC but few
have been evaluated to provide important lessons to support wider implementation. In Ethiopia
there is a gap in strategies to enhance male involvement in PMTCT program, which has not been
fully addressed in the country. Hence, this study is proposed to evaluate the effect of a
formal letter of invitation delivered through mother support group to the pregnant mother
attending her first antenatal contact without her partner to promote male partners'
attendance and HIV counselling and testing at antenatal care with his wife during a follow-up
period as per the new WHO ANC model recommendation schedule.
Hypotheses / Research Question(s) The investigator hypothesize that letter of invitation
through mother support group counseling will or will not promote or increase male
participation in PMTCT/ANC program as compared to a standard care (oral invitation)
The overall aim of the study is to evaluate the effect of letter of invitation delivered
through mother support group counselling on male involvement at antenatal care clinic
The specific objectives of this study are .
- To assess the prevalence of male involvement in prevention of mother to child
transmission of HIV and associated factors among women attending antenatal care in Bale
zone, Oromia region
- To explore selected groups of communities and health service providers experience and
perception concerning to benefits, challenges and approaches to increase men's
involvement in prevention of mother to child transmission services offered at ANC
facilities in Bale zone, Oromia region
- To investigate the effect of letter of invitation delivered through mother support group
to women attending antenatal care with out their partner on partner accompany and HIV
testing and counselling at subsequent antenatal clinic appointments in Bale zone, Oromia
region
- To explores experience of male partner who under went antenatal clinic after letter of
invitation in Bale zone, Oromia region Methods Study settings This study will be
conducted in Bale zone, which is one of the eighteen administrative zones in Oromia
Regional State. The study is carried out at two public hospitals, Goba general and Delo
Mena general hospital found in the zone. Goba general hospital is intervention while
Delo Mena general hospital is comparison sites. Both health facilities are similar in
proving basic antenatal care and PMTC of HIV service. Almost they do have similar health
service provider in the area and they have also comparable medical equipment to provide
ANC like laboratory and ultra sound.
Study design:
It is a six month study, a quasi experimental design using control groups and pertest will be
used to see the effect of letter of invitation on male involvement at antenatal clinic in two
hospitals located in Bale zone. Pregnant women visiting antenatal care without partners will
be eligible for the intervention and receive letter of invitation through mother support
group to invite their partners to attend at antenatal care clinic while the comparison groups
will continue to receive usual care. The primary outcomes include partner attendance at
subsequent ANC visits and secondary outcomes are partner counseling and testing Study
population All sampled pregnant women without partner who will visit the intervention and
comparison hospital for their first antenatal visit during the period of Jun 22, 2022 to
December 31, 2022 Inclusion criteria
- Confirmed pregnancy
- Pregnant women, until 34 weeks gestation. Gestational period is limited to 34 weeks to
allow room for suitable evaluation of the strategy as they report for antenatal care
- Pregnant women aged 18 years or older will be eligible
- Marriage or relationship with a woman visited ANC clinic during the study period.
- Pregnant women must be attending antenatal care without a spouse.
- willingness to provide informed consent before study participation
- Planning to attend the antenatal care at the study site on the subsequent visit.
- Permanent residents in intervention and comparison site.
- Partner who is generally accessible (i.e., not permanently working abroad).
- Women should be willing to pass on the invitation letter to their partner whereas in
comparison site as she is informed in routine care by antenatal care service provider
- Women has to be normal and expected to follow basic antenatal care Exclusion criteria
- Partner away from his permanent residents' area during data collections period
- Critical ill husband
Sample size:
A total of 400 participants will be enrolled in the intervention (n = 200) and control (n =
200) groups. Systematic random sampling technique will be used to select the study
participants from both intervention and comparison sites. The estimate is based on a Ugandan
study where male partners were invited for antenatal /PMTCT services using an invitation
letter. Based on the Ugandan Study, the assumption made is that male involvement in PMTCT
services will increase from 2% (without intervention) to 12% (with intervention) minimum
detectable difference between intervention and comparison sites is 10%. Using G Power 3.1.9.2
and Fisher's exact test with 95% power and 5% significance level, the sample size is
calculated based on the study conducted in Uganda by Byamugisha et al which is 166 in each
arm and after adjusting for a 20 % attrition rate the final sample size will be 200 in each
arm giving a total of 400.
Data Collection Instrument and Procedure:
Data will be collected through semi-structured questionnaires from eligible, consented
participants from both arms. Pregnant women will be eligible at any time point in pregnancy
but before 36 weeks gestation Primarily, the pregnant mother who has completed for her
respective routine antenatal visit in the intervention site will be linked to mother support
group by data collector and counselling given through them on the importance of male
involvement on the program then the women will be given the formal letter of invitation to
bring her partner on the subsequent antenatal visit. Within the control site, women do not
receive a letter, but will receive routine care (standard care) only to attend the next ANC
session with her partner by health service provider.
Statistical and Analytic Plan:
The data will be cleaned and coded then analyzed using IBM SPSS Statistics for Version 23.0.
Intention to treat analysis will be employed. The proportion of women who return to the
clinics with their partners and HIV test rate will be compared among the two arms using
chi-square test and McNemar's test will be used to compare two paired groups. Relative risk
with 95% CI will be computed to assess the effect of the intervention. Logistic regression
analysis is carried out to see independent effect of each variable on the outcome.
